Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

Past Events

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. 
 
Please RSVP to programs@rmras.org
 
Location: Front Range Community College   Room L-211, College Hill Library Westminster, Colorado 303-404-5539 

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

Slides from March 28 Webinar
March 28, 2018 Webinar.pdf
Adobe Acrobat document [9.4 MB]

Annual FDA Update

January 17,2018

Sheraton Denver West

Lakewood, C0

January 17, 2018 FDA Update
RMRAS_2018_ORA Program Alignment Externa[...]
Adobe Acrobat document [2.2 MB]
January 17, 2018 FDA Update-2
RMRAS January 2018_OMDRHO.pdf
Adobe Acrobat document [777.2 KB]
January 17, 2018 FDA Update-3
2018_RMRAS_ComplaintFiles.pdf
Adobe Acrobat document [897.3 KB]
January 17, 2018 FDA Update-4
OMDRHODIV3Inspectional Handout.pdf
Adobe Acrobat document [64.4 KB]

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. 

MedicalDevice Risk Management Overview
Medical Device Risk Management Overvew.p[...]
Adobe Acrobat document [1.4 MB]

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?

March 15, 2017 Presentation
RMRAS DHF Presentation (2017-03-15) Fina[...]
Adobe Acrobat document [908.7 KB]

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

2017 FDA Update presentation
FDA Update_RMRAS January 2017.pdf
Adobe Acrobat document [3.4 MB]

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
FDA Draft Modifications
FDA Draft Modifications - RMRAS Oct26201[...]
Adobe Acrobat document [285.1 KB]

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.

Going Global: Best Practices for Creating Content for Global Audiences
Going Global - Best Practices for Creati[...]
Adobe Acrobat document [1.5 MB]

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

 

LATAM Presentation (handout)_Carolina Ce[...]
Adobe Acrobat document [1.7 MB]

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. 

UDI Presentation - March 9, 2016 .pdf
Adobe Acrobat document [599.8 KB]

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.

 

2016 FDA Update Presentation
FDA Update - January 20 2016.pdf
Adobe Acrobat document [2.9 MB]
Capt Thomas Berry's presentation - 2016
Capt Thomas Berry Presentation 2016.pdf
Adobe Acrobat document [1.2 MB]
UDI presentation - Bryan Love - 2016
UDI Requirements and Resources3.pdf
Adobe Acrobat document [2.0 MB]
Questions and Answers - FDA Update, January 20, 2016
FDA Update 2016 - Questions and answers [...]
Adobe Acrobat document [282.0 KB]

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?  

2014

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” 

 

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Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

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