Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

Past Events

2017

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

 

Location: 

University of Phoenix - Westminster

8700 Turnpike Drive

Westminster, CO 80031

Quality System Regulation Course

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

 

March 15, 2017

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

 

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]

January 11, 2017

Annual FDA Update

 

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” 

 

Contact Us

Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

Follow Us