MDQC 2012 Agenda
PRE-CONFERENCE WORKSHOP: WEDNESDAY, MAY 16, 2012 |
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8:00 a.m. – 9:00 a.m. |
Registration and Continential Breakfast |
9:00 a.m. – 12:00 p.m. |
Writing for Compliance: Approaches and Methods for Writing High-Impact, Persuasive Compliance-Related Documentation within FDA-Regulated Companies Despite being one of the most regulated industry sectors in the world, attention to and development of even basic writing practices within most FDA-regulated organizations is almost nonexistent. With extensive requirements for bulletproof communication of complex technical and scientific concepts, and documentation required for almost every operational activity, highly technical personnel struggle to write to the appropriate audiences, and to choose the proper writing styles and techniques to effectively support their day-to-day business objectives. Even more striking is that many documents are never written with the anticipation and knowledge that an FDA inspector will likely read them in the future and use these documents as part of the overall determination of the organization’s compliance profile. Now, John C. (Jack) Garvey, Esq., Founder and Principal of Compliance Architects®, has developed an introductory workshop to help participants apply a collection of writing tools to achieve improved compliance outcomes within FDA-regulated companies. Based on his experiences of more than 25 years within the industry, Mr. Garvey will apply long-established writing principles to common writing challenges within FDA-regulated companies and help participants understand:
In addition, given the importance the FDA places on CAPA, Mr. Garvey will spend considerable time on techniques and approaches for improving the documentation of CAPAs, nonconformances, and other investigation and product analysis events. John (Jack) Garvey, Esq., Founder and Principal, Compliance Architects |
DAY ONE: WEDNESDAY, MAY 16, 2012 |
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1:00 p.m. – 1:15 p.m. |
Welcome and Introduction by Co-chair Steven Niedelman |
1:15 p.m. – 2:00 p.m. |
Keynote: New International Medical Device Regulators Forum (IMDRF) Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, CDRH, FDA |
2:00 p.m. – 2:45 p.m. |
Best Practices in Implementing an Effective Risk Management System Attendees will learn:
Dr. Vinny Sastri, President, Winovia LLC |
2:45 p.m. – 3:00 p.m. |
Refreshment Break |
3:00 p.m. – 3:45 p.m. |
Managing Risk in the Supply Chain Attendees will learn:
Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group |
3:45 p.m. – 4:30 p.m. |
Update on FDA’s Pathway to Global Product Safety and Quality Initiative Attendees will learn:
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, OC, FDA (invited) |
4:30 p.m. |
Adjournment |
DAY TWO: THURSDAY, MAY 17, 2012 |
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8:00 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Welcome and Introduction by Co-chair Elaine Messa |
9:15 a.m. – 10:00 a.m. |
Keynote: CDRH's Business Case Quality Initiative Attendees will learn:
Steven Silverman, Director, Office of Compliance, CDRH, FDA |
10:00 a.m. – 10:45 a.m. |
Case Study — Reducing Product Review Times and Steps to Ensure Smoother Global Approvals Attendees will learn:
Manuel Urena, Regulatory Affairs Manager, ResMed Ltd |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 a.m. |
The FDA's Seldom-Used Corporate Warning Letter — The Journey Back Attendees will learn:
Michael Crader, Vice President, Global Regulatory Affairs, Quality Assurance, Teleflex |
11:45 a.m. – 12:30 p.m. |
Crisis Management: How to Successfully Navigate Product Failures Defects in the Wake of Product Liability Litigation Attendees will learn:
Salena Zellers Schmidtke, BioInjury LLC |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:15 p.m. |
It Takes a Village to Effectively Manage CAPAs — How Covidien Developed Its "CAPA Board" Attendees will learn:
David Orton, Senior Director, Corporate Compliance, Covidien |
2:15 p.m. – 3:00 p.m. |
Design Control Practices for Medical Devices Attendees will learn:
Elizabeth Blackwood, Vice President, Supply Chain Quality Strategy, Johnson & Johnson |
3:00 p.m. – 3:15 p.m. |
Refreshment Break |
3:15 p.m. – 5:00 p.m. |
Panel Discussion: Latest on Postmarket Surveillance and How eMDR Will Change Quality Management and Reporting Responsibilities What better way than go straight to the source? FDAnews has convened top officials from CDRH’s Office of Surveillance and Biometrics to provide the latest updates and answer the tough questions.
Moderator:
Featured Speaker:
Panelists: |
5:00 p.m. – 6:30 p.m. |
Adjournment and Networking Reception |
DAY THREE: FRIDAY, MAY 18, 2012 |
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8:00 a.m. – 9:00 a.m |
Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Welcome and Introduction by Co-chair Steven Niedelman |
9:15 a.m. – 10:00 a.m. |
Keynote: ORA Enforcement Update Dara Corrigan, Associate Commissioner for Regulatory Affairs, ORA FDA (invited) |
10:00 a.m. – 10:45 p.m. |
Medical Device Recalls: Unique Challenges and Opportunities Attendees will learn:
Patricia Shrader, Vice President, Corporate RA, Medtronic |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:45 p.m. |
Panel Discussion: The 510K Overhaul and What it Means for Quality Professionals This panel of experts — including high-profile former FDA officials — will dissect the coming changes and discuss and debate how they will affect the quality departments and operations of device and diagnostic manufacturers. Panelists will also discuss how the pending IOM report on the more significant concerns could require more dramatic changes in quality management systems.
Moderator:
Panelists: |
12:45 p.m. – 1:00 p.m. |
Closing Comments by Co-chairs Steven Niedelman and Elaine Messa |
1:00 p.m. |
Conference Adjournment |