February 10-12, 2015  | Anaheim Convention Center | Anaheim, CA

2014 MD&M West Conference

EDUCATION | COLLABORATION | TRAINING

Conference Track C: FDA and Global Regulations in Practice

Refine and improve your PMA and 510(k) submissions and approvals, receiving the latest changes in regulatory guidelines and global updates, and essential guidance on process validation principles.

DAY 1 - Monday, February 10th
INTERPRETATIONS AND GUIDANCE ON REGULATORY UPDATES
9:00 AM Keynote Address

The consumer electronics movement to the medical device space

Dr. Peter Tippett, Chief Medical Officer & VP of Innovation Incubator, Verizon Enterprise Solutions
9:50 AM Move to track
10:10 AM Chair's opening remarks

Kim Walker, Principal Consultant, Kim Walker Consulting

10:15 AM PANEL DISCUSSION
What are the expectations of the regulatory agencies?

A panel of regulatory experts will start the day with a detailed discussion on the FDA expectations over the next 12 months and address the top 5 regulatory challenges facing the industry

Tim M. Lohnes, Senior Regulatory Consultant, Orchid Ortho
Michael Morton, Vice President, Regulatory Affairs, Medtronic
Elaine Tseng, Partner, King & Spalding LLP

10:45 AM EXPERT INSIGHT
Exploring FDA initiatives for FY 14
  • Examining recent initiatives of the US FDA to hasten the access of medical device technology
  • ssessing the mission and vision of the FDA’s Center for Devices and Radiological Health (CDRH)
  • Reviewing recent legislative changes intended to shorten the time to market and examining CDRH strategic priorities

Michael Morton, Vice President, Regulatory Affairs, Medtronic

11:15 AM WORKSHOP
How to reapply FDA feedback: Measure twice, cut once
This presentation will be based on 510(k) submissions, but the principals would serve for almost any interaction with FDA.
  • What is the FDA really asking for?
  • Is there a pattern to the feedback?
  • “Maybe the reviewer just had a bad day…”

Tim M. Lohnes, Senior Regulatory Consultant, Orchid Ortho

12:00 PM Lunch and Networking
1:00 PM Regulatory strategy for promotional marketing
  • Exploring the regulatory environment in the promotion of medical devices
  • Studying design and protocol development to support promotional marketing claims
  • Developing an internal team and processes to support promotional strategies and the review of promotional marketing material

Wilmar Estrada, Director, Advertising & Promotional Compliance, US Regulatory Affairs, Allergan

1:45 PM Responding to warning letters
  • Best practices in responding to FDA’s form 483 observations
  • Preparing an effective response
  • Promptly responding to warning letters and identifying the appropriate course of action
  • Developing a timeline for implementation

Jonathan M. Lewis, Principle, Advanced Biomedical Consulting

2:30 PM Networking Coffee Break
3:00 PM EXPERT INSIGHT
UDI: Keeping with the compliance timeline and implementation plan
  • UDI Project Assessment, Development and Execution
  • Large Scale Company versus Small Company Approaches: I have one product vs. I have thousands of models - where do I start?
  • Determining how much this will cost
  • Discussing the impact on current sustaining product and new product development

Dawn Fowler, Senior Manager, Labeling & Documentation, Endologix

3:45 PM CASE STUDY
Uncovering the advantages and disadvantages of GS1 and HIBCC UDI identification

Dr. Annemarie Belteu, Senior Business Analyst, Beckman Coulter

4:30 PM Welcome Drinks Reception


DAY 2 - Tuesday, February 11th
NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES
9:00 AM Keynote Address
The entrepreneurial journey

Rudy Mazzochi, CEO, Elenza
9:50 AM Move to track
10:10 AM Chair’s opening remarks

Peter Knauer, Senior Consultant, MasterControl

10:15 AM CASE STUDY
Uncovering the blind spots in 510(k) submissions
  • What an outside expert may see when you present a draft 510(k) for review before submission
  • Common mistakes seen in drafting illustrated
  • Understanding the 510(k) as an advocacy document, not just a data transmission
  • Beginning with the end in mind in your regulatory strategy and claims submission

Marjorie Shulman, Director, Premarket Notification (510(k)) Section, CDRH, FDA

11:00 AM EXPERT INSIGHT
Deciding when to submit a new 510(k) for a modified device – is a new regulatory approach needed?


  • Understanding the FDA’s current 510(k) modifications document and the standard
  • Knowing FDA’s current thinking reflected by the 510(k) modifications guidance forcibly withdrawn under FDASIA
  • Understanding how FDA becomes aware of potential modifications
  • How to deal with FDA in those situations

Mark DuVal, President, DuVal & Associates

12:00 PM Lunch and Networking
1:00 PM CASE STUDY
Frustrations of inconsistencies within FDA for Class III product updates

This presentation is about a Class III device that simply required a 30 day notice but was then told after 90-days that a PMA Supplement would be required.
  • CareFusion filed a 30-day notice for a change in the manufacturer of a stopcock for a water trap on a ventilator
  • 90 days later FDA responded to the notice and asked for a 135 day Supplement because, in their opinion, the change of the stopcock presents a risk to the patient.
  • We filed the supplement
  • FDA replied that this would now be a 30 day supplement

Donald J. Sherratt, Director Regulatory Affairs and Compliance, QRA Management, Respiratory Ventilation, CareFusion

1:45 PM EXPERT INSIGHT
Competitive regulatory strategy: Acting as a barrier to entry for your competitors

Michael Drues, Ph.D., President, Vascular Sciences

2:30 PM Networking Coffee Break
3:00 PM CASE STUDY
Getting FDA approval for changes to PMA products
  • How to work with your regulatory team while preparing the submission
  • Strategies to consider when determining the appropriate filing type (30-day Notice, 180-day PMA supplement, etc.)
  • How to best present your case why your change should be approved
  • Strategies for ensuring continued success with your post-PMA approval submissions

Janet D. Benson, Director Regulatory Affairs, US Post Approval and Core Products, Abbott Vascular

3:45 PM BRAINSTORMING SESSION
PMA submissions and approvals: Not a cookie cutter approach

Peter Knauer, Senior Consultant, MasterControl

4:30 PM End of Day 2


DAY 3 - Wednesday, February 12th
PROCESS VALIDATION PLANNING, EXECUTION & REPORTING
9:00 AM Keynote Address
Trends in mobile monitoring

Yan Chow, Director of Innovation and Advanced Technology, Kaiser Permanente

9:50 AM Move to track
10:10 AM Chair’s opening remarks

Thomas Oesterle, President, MedHouse Innovations, LLC

10:15 AM WORKSHOP
Process validation advanced principles

Thomas Oesterle, President, MedHouse Innovations, LLC
Bob Launsby, President, Launsby Consulting

12:00 PM Lunch and Networking
1:00 PM EXPERT INSIGHT
Cleaning Validation without Tears


For both single-use are reusable devices, cleaning is a blind spot that is too easy to ignore during initial product development. Cleaning involves more than sterilization.
  • “Pre-validating” the cleaning process
  • Using the 4Ds - define, develop, document, defend
  • Building IQ-OQ-PQ
  • Defining cleaning requirements and understanding cleaning process basics
  • Selecting a defensible cleaning process, minimizing leachable residue and avoiding materials compatibility issues
  • Selecting supply chain partners; defining their cleaning processes
  • Using recent ASTM and ISO guidance to streamline critical cleaning validation

Barbara Kanegsberg, BFK Solutions LLC
Ed Kanegsberg, BFK Solutions LLC

1:45 PM CASE STUDY
Low temperature sterilization process validation

During the past 15 years, new low-temperature sterilization processes have become commercially available. This presentation provides an overview of processes such as: vapor hydrogen peroxide sterilization, gas plasma sterilization, nitrogen dioxide sterilization, peracetic acid / hydrogen peroxide sterilization and low-temperature steam-formaldehyde sterilization. The presentation will also explain the validation approaches recommended for each of these processes. Finally, you will learn some of the unique challenges and pitfalls associated with these newer sterilization methods.

Rob Packard, Founder and Instructor, Medical Device Academy

2:30 PM Networking Coffee Break
3:00 PM EXPERT INSIGHT
Conducting the validation protocol, collecting and analyzing the data

Walt Murray, Director of Quality & Compliance Consulting Services, MasterControl

3:45 PM EXPERT INSIGHT
Process Validation – Fundamental Principles and Application of Basic Statistical Methods

  • Discussing guidance on Process Validation (GHTF/SG3/N99-10:2004 ed 2)
  • Preparing for Validation including process capability, measurement systems analysis (Gage R&R) and validation plans/protocols
  • Analyzing and documenting the results:
    • Testing distributional assumptions
    • Variable vs attribute data
    • Documenting results in the validation report

Ken Link, Medical Research Manager, NAMSA

4:30 PM End of Day 3


DAY 4 - Thursday, February 13th
GLOBAL PRODUCT DEVELOPMENT AND REGULATORY REQUIREMENTS
9:00 AM Keynote address
Building devices in a big data world

Shahid Shah, CEO, Netspective Communications but better known as the “The Healthcare IT Guy”

9:50 AM Move to track
10:10 AM Chair’s opening remarks

Chris Sarner, Project Manager, Medical Device Certification, DEKRA

10:15 AM EXPERT INSIGHT
China CFDA approval and registration in China
  • Examining the structure of CFDA (Chinese FDA)
  • Discussing the medical device registration process drug and device combination products
  • Clinical study requirements of Class II&III devices
  • Understanding the challenges and solutions for obtaining SFDA approval

Wenkai Ma, Director, Global Regulatory Affairs, Cerus

11:00 AM CASE STUDY
Breaking into the Brazilian market: Key product development and regulatory drivers in this Latin American medical device market
  • Exploring the market opportunity for medical devices in Brazil
  • Market and regulatory drivers promoting growth for medical devices in Brazil
  • Detailing regulatory hurdles for introducing medical devices into the market
  • Discussing market access and reimbursement drivers and barriers

Derek Archila, Director Research & Analysis, Medical Devices, GlobalData

12:00 PM Lunch and Networking
1:00 PM CASE STUDY
How to Leverage Engineering and R&D from India and China in the Med-Tech Business

Giants such as General Electric and Siemens employ thousands of engineers and scientists in India & China. But many other medical technology companies, small and large, are beginning to benefit from the technical talent in Asia. Gunjan Bagla and his team at Amritt have guided dozens of forward looking med tech CTOs and VPs of Engineering :

  • to expand their product pipelines and
  • to get to market faster in the face of budget pressure.
In this case study based presentation, Bagla will highlight the pros and cons of using global engineering, “captive” technical centers, and outsourced engineering partners. The real fears and opportunities of management as well as rank and file will be address and there will be plenty of time for your questions. Attendees will receive a copy of Bagla’s co-authored articles on global innovation from the Harvard Business Review.

Gunjan Bagla, Managing Director, Amritt

1:45 PM EXPERT INSIGHT
Medical device registration in South Korea
  • Understanding MFDS classifications of medical devices
  • Guide to preparing Korean MFDS medical device registration documents
  • Being compliant with Korean Good Manufacturing Practice requirements

Bruce Wang, Managing Director, Nova Global

2:30 PM Networking Coffee Break
3:00 PM EXPERT INSIGHT
Gaining insight into changing EU medical device regulations
  • Overview of current core EU directives: MDD, AIMDD and IVDD
  • Highlights of Proposed Regulations
  • Understanding the implications for medical device development and regulatory compliance

Chris Sarner, Project Manager, Medical Device Certification, DEKRA

3:45 PM BRAIN STORMING SESSION
Changes with global CAPA: What are the standard bodies looking for?
  • Implementing a standardized process across all global divisions
  • What are the main challenges whentryk can you harmonize your global CAPA system?

Andrew Harrison, Vice President of Business Development & General Counsel, Regulatory Compliance Associates Inc

4:30 PM End of Conference
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