2024

Rocky Mountain Regulatory Affairs Society 
presents
DEVICE PREMARKET SERIES
March through June, 2024
College Hill Library, Room 211
Front Range Community College, Westminster, Colorado

RMRAS’ Device Premarket Series features three, half-day courses with essential knowledge to help you develop and document your premarket device.
 

Design Control (March 27) will teach the basics of the design control process; how to create a design plan, inputs, and outputs; how to conduct a design review and effectively execute design transfer.
 

Risk Management (May 8) will explain the risk management process and types and purposes of risk analysis tools. Time will be allotted to a real-life risk analysis example.
 
Verification and Validation (June 12) will walk you through the basic types of verification and validation studies, writing the verification/validation plan, documenting the results, and recovering from verification and validation failures.

REGISTRATION OPTIONS
The courses have a variety of fee options for your use depending on how many people are attending.  See below:

Single Course Registration
The single registration fee for one of the Premarket Series courses is $325.00 including morning refreshments and course materials.

Group Discount Registration for Single Course
First two people from one company for one course is $325/each.
Third person from same company for same course is $295.
Fourth person from same company for same course is FREE!
[The free registration must be used for the same course as the others registered.]

The Payment Page on the website has all the details as to how to take advantage of these different options.

2023

Rocky Mountain Regulatory Affairs Society 
presents
Quality Systems: Focus on Fundamentals
Wednesday, March 15, 2023
9:00 am - 4:30 pm
College Hill Library
Front Range Community College, Westminster, Colorado

RMRAS is pleased to announce a new focus on the fundamental building blocks of all quality systems in its course “Quality Systems: Focus on Fundamentals.” Taking recommendations from past attendees and instructors, this streamlined one-day program will be taught by four quality/regulatory professionals including an FDA investigator (invited). The fundamentals to be emphasized are:

• Corrective and Preventive Actions (CAPA)
• Management Controls
• Design Controls
• Production and Process Controls

The new focus is intended to stimulate class interaction and sharing of real-world experience.

SPEAKERS
Matthew Bickford, Director of Quality System Compliance, Terumo Corporation

Matthew Bickford is a Colorado native and has a diverse background over his +20 years within the pharmaceutical and medical device industries.  After graduating with a degree in Molecular, Cellular, and Developmental Biology and Biochemistry, Matthew’s career began in pharmaceutical manufacturing and product development.  He then moved into biotech as a validation professional and then entered the medical device industry where he is currently the Director of Quality System Compliance within the Terumo Corporation.  Matthew also has a master’s degree in Engineering Management and is a Certified Medical Device Auditor from ASQ.

Bryant Hart, Senior Quality Consultant, ERI Group

Mr. Hart has 30+ years of technical experience including Quality System Management, Regulatory Affairs, Project Management, Design Control, Labeling, UDI, Risk Management, Manufacturing, Nonconforming Materials, CAPA, Auditing, Testing, Integration and Customer Support in the Medical Device and Industrial sectors.  Mr. Hart is experienced in managing product safety, performance and EMC testing, technical file maintenance, post-market surveillance, internal and supplier auditing, FDA inspections, ISO audits, Design Control, management reviews and QMS training.  A hands-on contributor, Mr. Hart has authored, implemented and maintained medical device Quality Management Systems necessary for US, EU, Canada and international compliance. 

John Mann, Vice President of Operations, ERI Group

Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality system planning and execution into the medical device design, development, and manufacturing continuum.  During his over 25 years in the medical device field, he has successfully implemented regulatory approvals for medical devices in both the US, EU and other global markets.  He has successfully mitigated and remediated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU and global market requirements.  Mr. Mann is adept at the implementation of and compliance with the FDA Quality System Regulation (QSR), ISO13485, ISO14971, ISO10993, 60601-1, IEC62304, ISO14155 and a broad range of other technology and device specific standards.  Mr. Mann is widely recognized for presentations and leadership in his field.

James Montero, Consumer Safety Officer, Division 3
Office of Medical Device and Radiological Health Operations, FDA

Mr. Montero received his bachelor of science degree in biology from Brigham Young University in 2008.  In 2009 I started as a Consumer Safety Officer with the FDA.  He has been conducting medical device inspections throughout the western states and internationally since 2010, inspecting everything from wound dressing and anti-snoring mouthpieces to fluoroscopic x-ray machines and transcatheter heart valve replacement systems. 

2022

August 17, 2022

Preparing for and Responding to FDA Inspections and

Possible Outcomes

RMRAS is extremely pleased to have Howard Manresa, Retired Director, Compliance Branch, Denver District Office, as our speaker for the  August 2022 meeting

PRESENTATION OVERVIEW
Mr. Manresa will discuss preparing for an FDA inspection, follow up to inspectional findings, and understanding the FDA’s options for regulatory action to bring firms into lasting compliance.
Learning objectives:

• Gain an understanding of what FDA investigators review while preparing for an inspection.
• Become familiar with the flow of the FDA inspection processes.
• Understand how to prepare for the initial meeting with the investigators.
• Learn how to manage the inspection – Documents and physical inspection.
• Closing-out the inspection and responding to investigators’ observations (the 483)
• Understand regulatory actions FDA can take to address non-compliance

SPEAKER BIO
     Mr. Manresa currently serves as an instructor, curriculum developer, CAG (Course Advisory Group) member, and expert panel member for the FDA’s Food and Drug Law II, Practical Compliance Applications, Introduction to FDA Fundamentals for ORA Mission Support Professionals, and Center for Veterinary Medicine’s Basics of Food and Drug Law for Administrative and Support Staff.
      He served as the Compliance Branch Director in the Denver District Office until August, 2014 having performed as a Consumer Safety Officer, RIC, SI, and CO as follows:           

• Investigator (CSO), Los Angeles District Office 1983-1986
• Resident-In-Charge (RIC), Fargo Resident Post (Fargo, North Dakota) 1986-1989
• Supervisory Investigator (SI), Minneapolis District Office 1989-1995
• Compliance Officer (CO), Minneapolis District Office 1995-2000
• Director, Compliance Branch, Denver District Office 2000-2014

April 1, 2022

2022 RMRAS Quality System Regulation PLUS

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

 
The Quality System Regulation PLUS Course is designed to provide students with a basic understanding of the requirements of the QSR regulation and the implications of the FDA proposed Rule on the Quality System. Regulation.

WHO SHOULD ATTEND?
This course is directed towards those who work within the design, implementation and maintenance of a quality system, and work in QA, R&D, manufacturing, and/or regulatory affairs. This is an introductory course offering a high-level overview of the regulatory requirements of QSR and the expectations of the ISO 13485:2016 standard.

COMMENTS FROM THE 2021 QSR ATTENDEES

“Great level of experience across all the speakers.  I really appreciated the examples and real-life stories.  This always provides chances to learn new things through the speakers’ years of experience. “

“Very good in translating into understandable language for novices like me!  I’m very impressed.”

“I would recommend or suggest that the rep FDA rep is very good to have in this class going forward!  His info was great. I liked being able to ask questions and listen to others that were put to him.”

SPEAKERS

RMRAS is pleased to have two experienced industry professionals as our instructors this year.

2021

Friday, September 24, 2021

2021 RMRAS Quality System Regulation PLUS
8:30 am - 4:30 pm

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.
 
The Quality System Regulation PlUS Course is designed to provide students with a basic understanding of the requirements of the QSR regulation and the ISO 13485:2016 standard.

WHO SHOULD ATTEND?
This course is directed towards those who work within the design, implementation and maintenance of a quality system, and work in QA, R&D, manufacturing, and/or regulatory affairs. This is an introductory course offering a high-level overview of the regulatory requirements of QSR and the expectations of the ISO 13485:2016 standard.

RMRAS is pleased to have two experienced industry professionals as our instructors this year.

John Mann, Director, Evergreen Research
Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality system planning and execution into the medical device design, development, and manufacturing continuum.  During his over 25 years in the medical device field, he has successfully implemented regulatory approvals for medical devices in both the US, EU and other global markets.  He has successfully mitigated and remediated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU and global market requirements.

Malissa Sailakham, Senior Quality Assurance Specialist, Corgenix
Quality Management System professional with 20 solid years of experience in Medical Device and IVD.  Specializes in QMS compliance, development, implementation, and evaluation of systems to ensure products and operations meet corporate objectives, integrity, and efficiency standards established by the organization and regulatory requirements.  Institutes continuous process improvement focused not only on product and service quality, but also on the means to achieve it.

Speaker Bio:

James Hildreth, OMDRHO Supervisory Consumer Safety Officer, FDA

James Hildreth is a Supervisory Consumer Safety Officer with the Office of Medical Device and Radiological Health Operations (OMDRHO) Division 3. He supervises a team of eight (8) Medical Device Investigators in the greater Los Angeles area, responsible for conducting inspections in the western half of the US, primarily in California, and abroad. Recently, James Hildreth was part of the team who developed and implemented the Remote Regulatory Assessment process for OMDRHO and has served as an internal contact for RRA questions for Division 3 since the implementation of the program. Since joining the FDA, and prior to assuming the role of supervisor in 2018, he principally conducted inspections of medical device manufacturers. Prior to government service, he obtained a Bachelor of Science in Biology from the Georgia Institute of Technology.

WEBINAR

Remote Auditing - Tips & Techniques

January 27, 2021

Learn from our panel of experts about their experiences with Remote Auditing.  
  4:00 pm - 5:00 pm

Sponsored by

EVERSANA

www.eversana.com

EVERSANA™ is the leading provider of global services to the life sciences industry. Our integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value. We serve more than 500 organizations, including innovative start-ups and established companies to advance life science solutions for a healthier world.
 

Please join us on January 27, 2021 for a  webinar on Remote Auditing.  Panel members have conducted and hosted several remote audits and will share their experiences and tips with the audience.  We encourage everyone attending to send in questions ahead of time to programs@rmras.org.  There will also be time during the webinar to comment and ask questions.

Our panel consists of four industry professionals are:

Nancy Sauer, Director of Regulatory Affairs, Medtronic Surgical Energy and Safety
Steve Beauchamp, Quality Director, Eversana

Darren Doherty, Director of Quality Assurance, Flagship Biosciences

Justin O'Neal, Quality Assurance Director, Eversana

2020

2020 Quality System Regulation Course (Online)

Friday, October 30^, 2020

8:00 am – 4:00 pm

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.  The Quality System Regulation Course is designed to provide students with a basic understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections.

This year we are presenting this course online and streamlining the program to focus on the following aspects of the regulation – Corrective and Preventive Actions, Design Controls, Production and Process Controls, Management Controls, and Records and Document Control.

Who should attend?

This course is directed towards those who work within the design, implementation and maintenance of a quality system, and work within QA, R&D, manufacturing, and/or regulatory affairs. This is an introductory course offering a high-level overview of the regulatory requirements of QSR.

Cost:

Cost for the course is $395.00. For companies wanting to register more than one attendee, a discounted fee is available.  Contact Nan Matthews, programs@rmras.org for details. Course material will be provided electronically.

Location: 

Online via Go to Training.  Links and directions for accessing the webinar will be sent in October.

Faculty

Ashleigh Wodushek – Principal Compliance Specialist, Medtronic  

Ashleigh Wodushek has been in the Medical Device Industry for over 10 years.  She started her career as an Investigator with the Food and Drug Administration in the Seattle District and later moved to the Denver District.  During her time with the FDA she focused on Medical Devices and conducted inspections both domestically and internationally.  Ashleigh was with the FDA about 7 years before joining Terumo BCT as a Quality System Compliance Auditor where she focused on supplier audits.  She then took on the role of Global Process owner for Quality Governance.  She then joined GID BIO, Inc. located in Louisville, CO as the Director of Quality and recently moved to Medtronic as a Principal Compliance Specialist.

Matthew Bickford, Director of Quality System Compliance, Terumo Corporation

Matthew Bickford is a Colorado native and has a diverse background over his 20 years within the pharmaceutical and medical device industries. After graduating with a degree in Molecular, Cellular, and Developmental Biology and Biochemistry, Matthew’s career began in pharmaceutical manufacturing and product development. He then moved into biotech as a validation professional and then entered the medical device industry where he is currently the Director of Quality System Compliance within the Terumo Corporation. Matthew also has a master’s degree in Engineering Management and is ISO 13485:2016 lead auditor certified.

Bryan Love, Special Assistant to the Program Director, Office of Medical Device and Radiological Health Operations (OMDRHO), FDA

Bryan has been in this position since June 2020 and is involved with developing and implementing several Strategic Priorities for the Medical Device Program within the Office of Regulatory Affairs.  Prior to this position, he supervised a group of Medical Device Investigators for OMDRHO Division 3 since program alignment started in May 2017.  That position involved the coordination of routine and compliance inspections of medical device establishments and the completion of CDRH directed assignments within the division. 

Webinar

Impacts of COVID-19 on Regulatory Affairs

Wednesday, September 9, 2020        4:00 pm - 5:00 pm

Webinar Sponsor

Corgenix

RMRAS is pleased to welcome Corgenix as the sponsor for our inaugural virtual panel discussion on the “Impacts of COVID-19 on Regulatory Affairs.” 

We have all been impacted in some way by the COVID-19 situation.  Join us in September for an engaging conversation with these regulatory professionals as they share their experiences and thoughts on this dynamic time.

Moderator:
Darren Doherty, Director of Quality Assurance, Flagship Biosciences

Panelists:

Evelyn Cadman, Principal Consultant, FDA Compliance Simplified

Evelyn Cadman is the owner and Principal Consultant for FDA Compliance Simplified, offering technology evaluation, product development and regulatory affairs services to the food, cosmetic, nutritional supplement and biotech industries. She has worked in regulatory affairs and product development for FDA-regulated products since 1997 and was previously at Pharmacologist at Abbott Laboratories. Evelyn recently authored and edited chapters on dietary supplement, cosmetic and food regulations in Fundamentals of US Regulatory Affairs, 8th Edition, and a chapter on food labeling in Nutritional Genomics: The Impact of Dietary Regulation of Gene Function on Human Disease.

Samir Ibrahim, Director, Regulatory Affairs, Patient Monitoring, Medtronic

Dan Simpson, Senior Director, Quality and Regulatory Affairs, Corgenix

Daniel Simpson, RAC (US,CAN), ASQ CBA.   Mr. Simpson is currently the Senior Director of Clinical and Regulatory Affairs at Corgenix Inc. which produces In Vitro Diagnostic (IVD) products for the clinical laboratory m.arket as a part of the ORGETEC Group of companies.  Mr. Simpson currently is in charge of all clinical and regulatory activity for the company’s current product portfolio.  Additionally, Corgenix offers contract development, clinical, regulatory, and commercialization activities for companies that have research diagnostic products for which they are seeking regulatory authorization as an IVD.   In this capacity, Mr. Simpson has developed regulatory and clinical strategies for submissions, market authorization, and registrations worldwide.  In the current COVID-19 pandemic, Mr. Simpson has been involved in several emergency use submissions with FDA, Health Canada, and ANVISA (Brazil). 

If you have questions, please contact Nan Matthews, programs@rmras.org or 303-843-6414

Annual RMRAS FDA Update

Wednesday, February 19, 2020

Sheraton Denver West

RMRAS is honored to again have LaTonya Mitchell, FDA Denver District Director, as our speaker for the annual RMRAS FDA Update scheduled for Wednesday, Februay19, 2020. She will be joined by members of her staff for a panel discussion.

As in the past, our members have been able to submit questions for the District Director’s comments, and Ms. Mitchell has kindly agreed to continue this tradition.  Therefore, please send your questions to programs@rmras.org by Wednesday,  February 12, 2020, and we will forward them for her review.

Schedule:

4:00 – 4:30   Registration

4:30 – 5:30  LaTonya Mitchell, FDA Denver District Director, and other FDA staff

5:30 – 7:00  Networking with refreshments and a cash bar

Location:

Sheraton Denver West

360 Union Blvd

Lakewood, CO 80228                 

303-987-2000

2019

Risk Management – 14971:2019 (Third Edition) – What Is Changing?

Thursday, December 5, 2019

College Hill Library, Westminster

3:30 – 4:00               Registration and networking

4:00 – 5:00               Risk Management – 14971:2019 (Third Edition) –

  What Is Changing?

RMRAS is pleased to have John Mann, Director, Evergreen Research as our December 2019 speaker.

Summary:

The program will review how ISO 14971 has evolved and what are the proposed changes in the third edition and the relationship to ISO 24971.  ISO 14971:2019 is scheduled to be published in December 2019. 

Speaker Bio:

Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the product design, development and manufacturing continuum.  During his over 25 years of experience in the medical device, IVD, tissue and various healthcare related products, he has successfully facilitated and driven global regulatory approvals for products to achieve business objectives; successfully managed and mitigated product correction and removals for large and small companies; and has designed and implemented Quality Management Systems (QMS) for products that are compliant to USA, EU, Canadian, global regulations and market expectations.

An Introduction to HIPAA & GDPR Compliance

for Medical Device & IVD

August 7, 2019

3:30 – 4:00           Registration and networking

4:00 – 5:00               Presentation

RMRAS is pleased to have Caitlyn Chavira, Senior RAQA Consultant, with Evergreen Research as our August 2019 presenter. 

Program Summary:

This presentation will summarize the history, requirements and potential pathways for complying with the requirements of HIPAA and EU GDPR in the medical device and IVD sectors, including registering with Privacy Shield, privacy policy examples and performing DPO assessments of your organization (do you or don’t you need one?)
 

Speaker Bio:

Ms. Chavira has just under a decade of experience as a quality and regulatory professional with diverse product portfolio experience in the regulated medical devices industry. With a background in quality systems and software quality engineering, and experience managing multi-location quality system organizations, Ms. Chavira has had critical impact on developing and bringing device innovation to markets in US, EU, Australia and China, and additionally maintaining established compliance in Japan, Brazil and Canada. She has assisted organizations in achieving successful ISO 13485:2016 certification, MDSAP certification, FDA breakthrough device designation and CE marking. Ms. Chavira has experience in risk management and assessment, quality systems program management, sterilization validation and process monitoring, bioburden analysis, product project management, international standards and regulation gap analysis, software classification and validation, GDPR assessment and compliance, materials compliance and is versed in general manufacturing engineering principals. She is also certified trained in MDR transition for CE marked devices in the EU.

2019 Quality System Regulation Course

Friday, June 21, 2019

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections.

This year we are streamlining the program to focus on the following aspects of the regulation – Corrective and Preventive Actions, Design Controls, Production and Process Controls, and Records and Document Control.

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs.   Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening.

Faculty

Ashleigh Wodushek – Director of Quality, The GID Group, Inc.

Ashleigh Wodushek has been in the Medical Device Industry for over 9 years.  She started her career as an Investigator with the Food and Drug Administration in the Seattle District and later moved to the Denver District.  During her time with the FDA she focused on Medical Devices and conducted inspections both domestically and internationally.  Ashleigh was with the FDA about 7 years before joining Terumo BCT as a Quality System Compliance Auditor where she focused on supplier audits.  She then moved into the role of Global Process owner for Quality Governance.  She recently joined The GID Group, Inc. located in Louisville, CO and is the Director of Quality. 

Amanda Zorn Shu, Senior Program Manager, Senior Compliance Auditor, Philips

Amanda Zorn Shu has been in the Medical Device Industry for over 10 years.  She started as an Investigator with the Food and Drug Administration in the Chicago District and later transferred to the Denver District.  Amanda earned her Level II Investigator Certification and became the Medical Device Specialist in the Denver District.  Amanda is currently employed by Philips as the Senior Program Manager for the Level 2 Corporate Audit Team as well as a Senior Compliance Auditor; she performs international and domestic audits for facilities aligned to a variety of regulations including 21CFR, EU MDR (MDD), CMDR, ISO 13485, ISO 9001, ANVISA, TGA, Chinese NMPA and Japanese PMDA.  She has also earned her ASQ certification for Quality Auditor and is ISO 13485 and 9001 Lead Auditor Certified.

Matthew Bickford, Director of Quality System Compliance, Terumo Corporation

Matthew Bickford is a Colorado native and has a diverse background over his 19 years within the pharmaceutical and medical device industries.  After graduating with a degree in Molecular, Cellular, and Developmental Biology and Biochemistry, Matthew’s career began in pharmaceutical manufacturing and product development.  He then moved into biotech as a validation professional and then entered the medical device industry where he is currently the Director of Quality System Compliance within the Terumo Corporation.  Matthew also has a master’s degree in Engineering Management and is ISO 13485:2016 lead auditor certified.

Annual RMRAS FDA Update

Tuesday, April 16, 2019

We are very pleased to announce that a Policy Analyst from the 510(k)/513(g) Program Team, CDRH, Dr Ifeanyi Uwemedimo, will be giving a 30-minute presentation via WebEx on Pre-Market Notification [510(k)] Process Overview, New Policies and Pilots at the April 16 RMRAS Annual FDA Update. 

The agenda is as follows:

4:00 pm       Registration and networking

4:30 pm       Overview of the Denver District        LaTonya Mitchell, District Director

4:45 pm       Pre-Market Notification [510(k)]       Dr Ifeanyi Uwemedimo

Process Overview…..                     CDRH

5:15 pm       Q&A Pre-Submitted Questions              

                   Mark Harris, Director Investigations Branch

                   Lauren Priest, Compliance Officer

                   Bryan Love, Supervisory Consumer Safety Officer

Dr Ifeanyi Uwemedimo’s Bio:

Ifeanyi Uwemedimo is a policy analyst in the 510(k)/513(g) Program Team in Center for Devices and Radiological Heath (CDRH), Food and Drug Administration.  Dr. Uwemedimo has been with CDRH since 2012.  Before serving on the 510(k)/513(g) Program Team, she was a lead reviewer in the Division of Cardiovascular Devices (DCD). Some of her accomplishments include drafting guidance documents, training staff, and assisting in the implementation of new policies to help reduce total time to decision (TTD). Dr. Uwemedimo has been on numerous policy-setting groups within the FDA.  Most recently, she was active with the 510(k) Benefit Risk Guidance working group. Dr. Uwemedimo received a doctorate degree in biomedical engineering from Syracuse University and her undergraduate degree from Smith College,

“An Overview of the New Medical Device Regulation”

March 26, 2019

RMRAS is very pleased to have Dr. Michael Rinck, Managing Director, MT Promedt Consulting GmbH from Ingbert, Germany as our morning speaker on the new medical device regulation.

His presentation will include:

Part 1: General introduction on new EU Regulations MDR/IVDR

Part 2: CE certification of medical devices under MDR

With following topics

• QMS and MDR
• Product Classification
• Technical Documentation
• Clinical Evaluation
• PMS

He will also focus on the new responsibilities under MDR/IVDR.

Dr. Rinck’s Bio:

An independent consultant with over 30 years of international experience in developing and implementing corporate strategies in the areas of quality systems and regulatory compliance for the health care industry. He combines strong experience in quality, compliance and regulations with a pragmatic approach at both operational and strategic level. Specific expertise in production of sterile disposables, biocompatibility (ISO 10993) and clinical evaluation, quality systems and regulatory affairs for medical devices and API’s. Experience in international supplier audits, implementation of relevant QM modules such as complaint handling, Post Market Surveillance and medical device vigilance systems, CAPA and change control systems. Strong experience in validation projects for ETO sterilization (ISO 11135), sterilization with irradiation (ISO 11137) and chemical sterilization (ISO 14937). Project activities included definition of validation strategies, coordination of validation activities and external laboratory testing as well as coordination with Notified Bodies

2018

Hazard Analysis and FMEA

November 7, 2018

 3:30 – 4:00               Registration and networking 
 
4:00 – 5:00               Presentation 
 
RMRAS is pleased to have as our November speaker John Mann, Director, Evergreen Research, who will discuss the logistic details of doing a Hazard Analysis and FMEA.
 
Speaker Bio: Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the medical device design, development and manufacturing continuum.    During his over 25 years’ experience in the medical device field, he has successfully implemented regulatory approvals for class 1, class 2 and class 3 devices in both the USA and EU, he has successfully mitigated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU, Canadian and other global regulations.  In addition, he has successfully remediated systems and records for companies under rigorous regulatory oversight.  Mr. Mann is adept at the implementation of and compliance with the FDA Quality System Regulation (QSR), ISO13485, ISO14971, ISO10993, 60601-1, IEC62304, ISO14155, IEC 62366-1, HE-75 and a broad range of other technology and device specific standards.  Mr. Mann is widely recognized for presentations and leadership in his field. 
 
 

2018 Quality System Regulation Course

Friday, June 15, 2018

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.  The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections.  This year we are streamlining the program to focus on the most important parts of the regulation – CAPA, Complaint Handling, Non-Conformance, Validation, plus a few others

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs.   Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening.

Cost:

Cost for the course is $395.00 including all course materials, QSR booklet, continental breakfast and lunch. 

Location: 

PPA Event Center, 2105 Decatur Street, Denver, CO 80211 [immediately north of Sports Authority Field]

Faculty

Ashleigh Wodushek, Global Process Owner – Quality Governance, Terumo BCT

Ashleigh Wodushek has been in Colorado for the past 6 years and prior to that was in Portland, OR.  She has her undergraduate degree in Biology and Chemistry and a Masters’ Degree from Colorado State University.  She started her career as an Investigator with the Food and Drug Administration in the Seattle District and later moved to the Denver District.  During her time with the FDA she focused on Medical Devices and conducted inspections both domestically and internationally.  Ashleigh was with the FDA about 7 years before joining Terumo BCT as a Quality System Compliance Auditor where she focused on supplier audits.  Now she is the Global Process owner for Quality Governance and is responsible for the Global Audit process, Global Training and Personal process, and the Global Management Responsibility process.

Amanda Zorn, Program Manager, Senior Compliance Auditor, Philips

Amanda Zorn has been in the Medical Device Industry for over 9 years.  She started as an Investigator with the Food and Drug Administration in the Chicago District and later transferred to the Denver District.  Amanda earned her Level II Investigator Certification and became the Medical Device Specialist in the Denver District.  Amanda is currently employed by Philips as the Program Manager for the Level 2 Corporate Audit Team as well as a Senior Compliance Auditor.  She has also earned her ASQ certification for Quality Auditor and is ISO 13485 and 9001 Lead Auditor Certified.

Non-Product Computer System Validation

April 11, 2018

3:30 – 4:00         Registration and networking

4:00 – 5:00               Presentation

RMRAS is pleased to have Larry Sampson and Dennis Nevins of Siemens PLM Software as our April speakers.

Program Summary:

Speaker will:

• Review of draft guidance content.  Speaker will discuss some of the suggested guidance content, but in a summary format.  It is assured the guidance will be different in final format, but it is instructive of what the FDA thinks about non-product software and the advantages of employing automation
• Run through a work flow Siemens is using, and how it attempts to automate compliance with the guidance
• Will discuss:
  • how the workflow integrates with product risk
  • how the workflow integrates the supplier evaluation
  • one method how to integrate quality system risk and how this can drive the type of testing required for validation
• how to integrate several validation methods based on other industry experiences.

Speaker Bios:

Larry Sampson

Senior Director Medical & Lifescience Industry Strategy

Siemens PLM Software

Laurence is currently the Senior Director, Medical & Life Science Industry Stragegy for Siemens PLM. Siemens is uniquely positioned to provide solutions for management of product design controls, PLM, manufacturing execution, and post market management of life science products.

Laurence is an accomplished operations manager with over 20 years of medical device experience. He is systems minded, and has developed integrated programs for product design controls, risk management, cGMP device production, CAPA, complaint handling, and other systems supporting the production of medical devices sold on domestic and international markets.

Dennis Nevins

Siemens Polarion ALM Portfolio Development Executive

Successful enterprise software sales professional with 16+ years experience plus an additional 9+ years in sales management roles. Skilled “Hunter” sales person who has exceeded personal quota in 12 of 16 years. Very experienced in selling enterprise IT security and compliance software solutions. 

 Webinar on

Part 11 and Computer System Validation

March 28, 2018 

This webinar describes exactly what is required for compliance with Part 11 for local and SaaS/Cloud hosted applications.  What the regulation means is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Learning Objectives/Areas Covered:

• Which data and systems are subject to Part 11
• What the regulations mean, not just what they say
• Avoid 483 and Warning Letters
• Requirements for local, SaaS, and cloud hosting
• Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
• How to use electronic signatures, and ensure data integrity, and protect intellectual property
• SOPs required for the IT infrastructure
• Product features to look for when purchasing COTS software
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Presenter:

David Nettleton, FDA Compliance Specialist, Computer System Validation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project

Annual FDA Update

January 17,2018

Sheraton Denver West

Lakewood, C0

2017

Medical Device Risk Management Overview

Application throughout the product lifecycle

December 6, 2017

College Hill Library, Westminster, CO

RMRAS is pleased to have John Mann, Director, Evergreen Research, as our speaker.

Program Summary:
The presentation will be a high-level overview of risk management according to ISO 14971:2012 and will address key concepts of risk management over the product life cycle including development, production and post-production.  In addition, the application of ISO 14971 will demonstrate how the risk management ensures conformity to other standards such as 60601-1 and 62366-1 and how a company can fulfill its requirements for post market surveillance. 

Speaker Bio:

Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the medical device design, development and manufacturing continuum.  During his over 25 years' experience in the medical device field, he has successfully implemented regulatory approvals for class 1, class 2 and class 3 devices in both the USA and EU; he has successfully mitigated recall and market withdrawal situations for large and small companies; and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU, Canadian and other global regulations. 

Why Third-Party Reimbursement Is Critical to the Development of Medical Products

October 18, 2017

 Westminster, CO

RMRAS is pleased to present, Carolyn R. Moora, CPC, President, Reimbursement Principles, as our October speaker.       

Summary of Presentation:

The presentation will describe:

• what reimbursement is
• why positive coverage is important for new medical devices/technologies
• real-life examples of what went wrong and what went right
• a continuum of the reimbursement process throughout the product life cycle (from concept through market launch).
• how reimbursement mistakes can cause marketing failure for medical devices
• TAVR cases which are being aggressively marketed to patients by manufacturers 

Speaker Bio:

Carolyn Moora is a veteran consultant to health-care professionals including technology company executives, hospital administrators, physicians, audiologists, occupational and physical therapists and others specializing in medical finance, reimbursement, marketing, and strategic business planning.   She specializes in reimbursement issues for medical device and pharmaceutical manufacturers including reimbursement during clinical trials.   Prior to launching her consulting practice in 1998, she spent eleven years developing reimbursement and marketing strategies for highly innovative medical technology companies specializing in implantable functional electrical stimulation products such as the cochlear implant, and implantable products that restore movement to spinal cord injury patient.  Ms. Moora has published and lectured extensively on successful reimbursement strategies.  Ms. Moora is a Certified Professional Coder (CPC) credentialed with the American Academy of Professional Coders.

Process Validation for Medical Devices

Tuesday, October 3, 2017

8:15 am – 5:00

This one-day Process Validation workshop intends to help make process validation a useful activity, with payback and not just cost.  The presenters believe value-added process validation requires cross-functional interactions and aim to foster discussion among attendees at various levels of expertise, and in different positions within their firm’s organization chart. 

The workshop will include information, discussion, and case studies based on the following questions:

• Why validate?
• When to verify?
• Does design control impact process validation?
• How does validation and verification relate to risk?
• What is needed to document validation?
• Can we justify the cost of process validation?

Speaker Bios

Neil Burris - CBA, RAC, RM (AAM)

Neil Burris entered the medical device business in 1988, working for a manufacturer of implantable cardiac pacemakers.  Mr. Burris’ various experiences in Quality Systems, Contamination Control, Clinical Data Management, and Sterilization Science combine to form a background particularly suitable for understanding Regulatory Affairs for Medical Devices.  He strives to aid in facilitating the legal sale of ethical, safe, and effective devices.  He has previously served on standards writing committees for the Association for the Advancement of Medical Instrumentation (AAMI) and the Institute for Environmental Sciences and Technology (IEST).  He currently serves on the Steering Committee Rocky Mountain Regulatory Affairs Society, and earns a living via a successful independent consulting practice.  Neil Burris was formally educated at Colorado State University, and holds degrees Chemistry and Microbiology.  He is a Certified Biomedical Auditor, Regulatory Affairs Certified, and a Registered Microbiologist.

Jeff Dupont, Jeff Dupont, VP of Quality Consulting,  Dohmen Life Science Services   Jeff’s more than 12 years of quality and operations experience has involved responsibility from research/development to post-market with a large number of domestic and global companies within the medical device, biologics, and pharmaceutical industries.  Jeff is also experienced in compliance and working with R&D, Marketing, Sales, Legal, Manufacturing, Regulatory, and Supply Chain organizations.  Jeff is currently the VP of Quality Consulting for DLSS and is responsible for running the Quality Consulting service line servicing Medical Device, Biologics, and Pharmaceutical industry segments.  Jeff also works closely with DLSS’ Quality Management System Outsourcing (including DLSS’s Donor Eligibility System) service line in order to provide Quality Consulting resources to support these services

Quality System Regulation Workshop

Thursday, June 29, 2017

8:00 am – 5:00 pm

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections. Practical solutions as well as consequences of non-compliance will also be covered.

Lunch with the FDA

We are very pleased to announce that we will have a FDA Panel consisting of representatives from both the Compliance and Investigations branches join us again this year. They will address questions submitted by the attendees as well as reviewing current Agency trends and directions.

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs.   Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening

Design History File: Elements of and maintenance/remediation of the Design History File

March 15, 2017

Program Summary

Companies commonly face the challenge of assessing and updating design history files (DHF) as a result of design obsolescence, product updates, transfer of design ownership and changing regulatory requirements.  This seminr will provide an overview of DHF requirements, present for DHF gap analysis and remediation, and offer a checklist of critical DHF assessment areas for complex medical devices. 

Topics to be covered

What is the Design History File?

Why is an effective DHF good for business?

Design History File checklist

FDA critical DHF assessment area

Common DHF deficiencies

Why/When is a DHF gap analysis warranted?

Annual FDA Update

January 11, 2017

RMRAS is honored to again have LaTonya Mitchell, Denver District Director,  Captain Thomas Berry, Director of Compliance Branch, and Mark Harris, Director of Investigations Branch,  join us for their annual update.

4:00 - 4:30     Registration

4:30 - 5:30     FDA Panel Presentation

5:30 - 7:00     Refreshments, cash bar and networking

2016

October 26, 2016

When Product Changes Require a New 510(k) –

Overview and Discussion on FDA’s New Draft Guidance Documents

Summary of Presentation:

In August, FDA released two draft guidance documents related to when product changes require a new 510(k)—one is specific to software changes and the other addresses all other types of changes. The final versions of these guidance documents will affect your business for years to come.

Come learn more about FDA’s proposals before the comment period closes on November 6!

The presentation will cover:

•  An overview of how FDA collected stakeholder input when developing the documents
•  How the draft guidance differs from the current guidance document (K97-1)
•  Differences between the general modifications guidance and the software modifications guidance
•  What is positive in the draft guidance documents
•  Potential challenges posed by the draft guidance documents

July 27, 2016

Going Global:  Best Practices in Creating English Content for Global Audiences

Rocky Mountain Regulatory Affairs Society is pleased to present Michael Webb, Business Development Director, Lionbridge Life Sciences as our July, 2016 speaker.

In today’s global economy international expansion can provide key areas for growth across companies within the Life Sciences sector. While the growth potential of new markets is extremely attractive, the process of translating your content to enter most markets can become a time consuming and costly expense, but optimizing English content can make translation a much more efficient process. This one-hour session will focus on best practices for creating documentation and labeling in English that is optimized for translation, helping to reduce timelines and overall costs.

Speaker Bio

Mike Webb is a Colorado native and a Director at Lionbridge Life Sciences, the global leader in language translation solutions. Mike manages the Western half of the US for Lionbridge, working specifically within Life Sciences and Healthcare Arenas. Having worked in the translation field for over 9 years he has significant experience in helping Medical Device, Pharmaceutical, and Biotech companies reach their patients, employees, and Partners across the globe.

June 15, 2016

Designing a Clinical Study: Start with the End in Mind

Rocky Mountain Regulatory Affairs Society is pleased to present Jaime Ritter of Bard Medical in Atlanta, Georgia. 

Session Summary: 

Unfortunately, it is all too common to hear “I thought we were collecting X” or “can we analyze Y” at the end of a clinical study.  When designing and executing a clinical study it is critically important to consider what your customer (i.e., sales, marketing, research and development, etc.) ultimately wants at its conclusion.  Early involvement in the new product development process and partnership with key stakeholders is essential to ensure that clinical studies are not only successful from a results perspective but also from a usability one.  This 1-hour session will focus on the design of clinical studies from the concept phase of product development through post-market, highlighting best practices, regulatory compliance, and practical considerations.   A brief summary of the clinical study execution process will also be included.

June 2, 2016

Quality System Regulation Course

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections. Practical solutions as well as consequences of non-compliance will also be covered.

April 20, 2016

Overview of the Regulatory Environment in Latin America

RMRAS is pleased to present Carolina Cera, Regulatory Affairs Specialist, as our April 2016 speaker      

Summary of Presentation:

In the last decade Latin America has had explosive economic growth leading medical device companies to focus on this region. These emerging markets offer increasingly more opportunities with limited competition; however, it brings other challenges in terms of regulatory compliance. The regulatory environment is not yet mature and regulations continue to change rapidly with the goal of assuring safe and effective products to the population. This presentation will address an overview of the regulatory environment in the region and also explore challenges and business partnerships in key markets.

Speaker Bio:

Carolina Cera is a native Brazilian from the city of Sao Paulo, who for the last three has lived in Denver, Colorado. She has been working with Regulatory Affairs since 2008, with strong expertise in Latin America regulatory compliance. Her experience over the last 8 years includes more than 90 registration submissions throughout Latin America including Brazil, Argentina, Colombia, Mexico and Panama. She earned her pharmacy degree through Oswald Cruz University in Sao Paulo, and currently is working as a Regulatory Affairs Specialist for Terumo BCT

March 9, 2016

The Long and Winding Road of Unique Device Identifier (UDI) Implementation:

A Small Company Perspective

Rocky Mountain Regulatory Affairs Society is pleased to present Dan Simpson, Senior Director of Quality and Regulatory Affairs, Corgenix as our March 2016 speaker.

As many Class II Medical Device Manufacturers busily prepare for the September, 2016 compliance deadline for the UDI final rule, this presentation will dive into what is known and unknown regarding the UDI requirements. 

Dan will review the current requirements, the challenges he has encountered during his UDI experiences, and lessons that have been learned.  Everyone’s unique company experiences are welcome as we will discuss unique questions and problems and the available resources to get the right answers. 

January 20, 2016

RMRAS ANNUAL FDA UPDATE

RMRAS is honored to again have LaTonya Mitchell, FDA Denver District Director, as our speaker for the annual RMRAS FDA Update scheduled for Wednesday, January 20, 2016.  She will be joined by Capt. Thomas Berry, Director of Compliance Branch and Bryan Love, Supervisory Consumer Safety Officer.

2015

January 14, 2015

System and Software Verification and Validation

Speaker Bio:

Mr. Gupta was a Senior Manager in R&D and has had held several positions with CaridianBCT/ Gambro BCT/COBE BCT (currently Terumo BCT). He is currently providing consulting services to various organizations around the United States

He is a professional with over 25 years hands on and management experience in Medical Devices in system and software quality assurance, risk analysis and management, regulatory affairs and product development. His expertise includes:

·         System and Software Quality Assurance

·         System and Software V & V

·         Cross functional team leadership

·         Regulatory Submissions/Compliance

·         Project Management

·         CAPA review, response  and remediation

·         Risk Analysis and Management

·         FDA and International Standards and Regulations (ISO 62304, ISO 14971, ISO 13485,  IEC 60601, IEC 61010, and IEC 62366)

March 16, 2015

Introduction to Risk Management

EN ISO 14971: 2012 Medical devices: Application of risk management to medical devices          

Speaker Bio:

Terri Kurtz has over 20 years of experience providing consulting and project management for the development design, validation and manufacture of medical devices and pharmaceuticals. She received her Bachelor of Science in Chemical Engineering from the University of Colorado and her Master of Business Administration from Regis University.

ility Engineering Process per EN 62366

May 15, 2015

RMRAS Quality System Regulation Course

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections. Practical solutions as well as consequences of non-compliance will also be covered.

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs.   Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening.

June 26, 2015

Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control)

Failure Investigation Methodology

This three hour program will cover:

• Use of DMAIC concept to tackle non-conformances
• The concept is easy to use and understand
• DMAIC methodology tackles harder problems via better understanding of variances, probabilities, and risk management
• The use of non-DMAIC approach is bound to eventually lead to wrong solutions, no solutions, too many solution implementations, and longer resolution times

Speaker Bio:

Veronica Guerrero, Quality Engineering Manager, C. R. Bard, Inc.

Veronica has more than 15 years of experience in Quality Assurance and Quality Engineering in the Medical Device and Consumer product industries. She has extensive experience in Quality Engineering in Design and Development and Manufacturing, Quality Assurance, Manufacturing Engineering, Risk Management, Lean, Six Sigma, Statistical Techniques, and Software QA.

August 5, 2015

Regulatory Affairs Certification - Do You Want to Be a RAC?

Topics to be covered:

• RAC Body of Knowledge
• Reference Resources
• Suggestions for Study Strategy
• Networking for Support or Study Groups

A Panel of “RAC’s” has planned a short presentation on what the Regulatory Affairs Certification process is and why you might choose to spend the money and time it takes to add "RAC" to your credentials.  The Panel will try to answer questions and allow for some thinking out loud about the RAC exam.

The Regulatory Affairs Professionals Society (RAPS) administers RAC four certification exams:  United States, Canada, European Union, and Global.  The RAC Exams will be given once more in 2015.  The registration deadline and examination dates are:  September 1st ($425 RAPS members/$525 nonmembers); October 1, through November 30 for test administration in 2015. 

September 30, 2015

A Conversation with Howard Manresa

Former Director of Compliance,  FDA Denver District Office

Rocky Mountain Regulatory Affairs Society is pleased to present Howard Manresa, Former Director of Compliance, Denver District FDA, as our September 2015 speaker.

With over 30 years at the FDA, Howard will share his thoughts on 

• new businesses entering into regulated industry,
• what FDA expects to see when they assess a firm's compliance,
• how firms respond to inspections and inspectional findings,
• when you need to consider a consultant, and
• other topics of interest from the participants.

November 12, 2015  

Process Validation for Medical Devices

After the success of this class in 2014, we have decided to hold it again in order to reach those people who were unable to attend last year.

  
This one-day Process Validation workshop intends to help make process validation a useful activity, with payback and not just cost.  The presenters believe value-added process validation requires cross-functional interactions and aim to foster discussion among attendees at various levels of expertise, and in different positions within their firm’s organization chart.    
The workshop will include information, discussion, and case studies based on the following questions:  

• Why validate?  
• When to verify?  
• Does design control impact process validation?  
• How does validation and verification relate to risk?  
• What is needed to document validation?  
• Can we justify the cost of process validation?  

February 25, 2014

Regulatory Affairs Certification (RAC)

Topics to be covered:

   RAC Body of Knowledge

   Reference Resources

   Suggestions for Study Strategy

   Networking for Support or Study Groups

The presenters have planned a short presentation on what the Regulatory Affairs Certification process is and why you might choose to spend the money and time it takes to add "RAC" to your credentials.  We will try to answer questions and allow for some thinking out loud about the RAC exam.

The Regulatory Affairs Professionals Society (RAPS) administers RAC four certification exams:  United States, Canada, European Union, and Global.

April 16, 2014

Recent Trends and Upcoming Changes in the 510(k) Process

A Report from the Advamed 510(k) Working Group and Panel Discussion

Rocky Mountain Regulatory Affairs Society is pleased to present four industry professionals as our April speakers reporting on the Advamed 510(k) Working Group’s recent meeting.

MDUFA III and FDASIA have had significant impacts on FDA's 510(k) process. This session will provide some insight into what has been happening and how these changes may affect your company's submissions. Topics will include:

• The new Refuse to Accept 510(k) screening process - Issues from the first year and how to avoid rejection of your submission
• Recent metrics on 510(k) review times
• The status of new guidance on when to submit 510(k)s for changes to existing devices
• Pre-submission meetings--overview of new guidance on report on companies' experiences

This will be followed by an open discussion on recent experiences of Front Range companies--bring your war stories and success stories. Share tips with your colleagues

May 21, 2014

Why Third Party Reimbursement Is Critical to Medical Product Development

The presentation is aimed at introducing the following elements to drug, tissue and device manufacturers:

• Convey importance of third party reimbursement
• Identify elements of third party reimbursement
• Help audience identify which reimbursement activities correspond with the various stages of technology development
• Provide audience topics to consider and revisit during technology development
• Provide examples of reimbursement mistakes as well as an example of how to plan for successful reimbursement

Speaker Bio:

Marisa Herder is a clinical trial reimbursement specialist for Reimbursement Principles, a full service medical device consulting firm in Highlands Ranch.  She helps secure and oversee reimbursement for various clinical trials and works closely with physicians, hospital staff and regulatory departments to train and assist with various reimbursement aspects during the life cycle of a clinical trial.  Mrs. Herder also works closely with the Medicare Administrative Contractors (MACs) during the course of the trial, helping investigator sites to apply and obtain third party reimbursement.

June 24, 2014

RMRAS Quality System Regulation Course

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections. Practical solutions as well as consequences of non-compliance will also be covered.

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs.   Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening.

October 3, 2014

Process Validation for Medical Devices

After the success of this class in 2014, we have decided to hold it again in order to reach those people who were unable to attend last year.

  
This one-day Process Validation workshop intends to help make process validation a useful activity, with payback and not just cost.  The presenters believe value-added process validation requires cross-functional interactions and aim to foster discussion among attendees at various levels of expertise, and in different positions within their firm’s organization chart.  

 
The workshop will include information, discussion, and case studies based on the following questions:  

• Why validate?  
• When to verify?  
• Does design control impact process validation?  
• How does validation and verification relate to risk?  
• What is needed to document validation?  
• Can we justify the cost of process validation?

October 22, 2014

Recent FDA Enforcement Actions and Areas to Watch:

 A QA/RA Panel Discussion

Rocky Mountain Regulatory Affairs Society is pleased to present a panel discussion on recent FDA enforcement actions.

Topics will focus on premarket and post-market enforcement actions; and will be discussed by a panel of expert QA/RA professionals. Specific topics to include:

• Off label promotion;
• Packaging validations;
• Laboratory developed tests

Panelists

Stacci Cronk, Senior Regulatory Affairs Specialist, C.R. Bard

Ian Marsden, Regulatory Affairs Manager, Dohmen Life Science Services

Dan Simpson, QA/RA Manager, Corgenix

November 12, 2014

RMRAS Annual FDA Update

RMRAS is honored to again have LaTonya Mitchell, FDA Denver District Director, as our speaker for the annual RMRAS FDA Update scheduled for Wednesday, November 12, 2014.  She will be joined by Capt. Thomas Berry, Director of Compliance Branch and Bryan Love, Supervisory Consumer Safety Officer.

The focus of their presentation this year will be “Supplier Controls: FDA Perspective”