MDQC 2011 Agenda
PRE-CONFERENCE WORKSHOP: TUESDAY, JUNE 7, 2011 |
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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 develop-ment of even basic writing practices within most FDA-regulated organizations is almost nonexis-tent. With extensive requirements for bulletproof communication of complex technical and scien-tific 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 deter-mination 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 experi-ences 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, Jack 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: TUESDAY, JUNE 7, 2011 |
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12:00 p.m. – 1:00 p.m. |
Registration/Lunch |
1:00 p.m. – 1:15 p.m. |
Welcome and Introduction by Co-chair Steven Niedelman |
1:15 p.m. – 2:00 p.m. |
Opening Keynote: Supplier Controls — FDA Medical Device Requirements Attendees will learn:
Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA |
2:00 p.m. – 2:45 p.m. |
Managing Global Risk Management Programs To Assure User Needs Are Met Attendees will learn:
Dr. Ray Silkaitis, Director Scientific Affairs, Hospira |
2:45 p.m. – 3:00 p.m. |
Refreshment Break |
3:00 p.m. – 3:45 p.m. |
Utilizing Risk Assessment to Manage OEM/Contract Suppliers Attendees will learn:
Jacqueline Torfin, Vice President of Quality, Heraeus Medical Components |
3:45 p.m. – 4:30 p.m. |
Detecting, Controlling and Preventing Quality Problems — Best Practices for Advancing Product Quality Across Extended Supply Chains Attendees will learn:
Jay Antonellis, Senior Director, Life Science Practice, Camstar Systems |
4:30 p.m. – 6:00 p.m. |
Panel Discussion: 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: Elaine Messa, Director, Medical Device Quality Systems and Compliance Practice, Becker & Associates Consulting, Inc Panelists:
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6:00 p.m. |
Adjournment |
DAY TWO: WEDNESDAY, JUNE 8, 2011 |
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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. – 10:15 a.m. |
FDA Update on How Science Shapes the Agency’s Regulatory Decision-making Attendees will learn:
Steven Pollack, Center Director, Office of Science and Engineering Labs, CDRH, FDA (invited) |
10:15 a.m. – 11:00 a.m. |
Applying Risk Management in a Straightforward Manner — Utilizing a Single, Closed Loop Flowsheet for Product Review Attendees will learn:
Barrett Craner, Vice President, QA/RA, Stellartech Research Corporation |
11:00 a.m. – 11:15 a.m. |
Refreshment Break |
11:15 a.m. – 12:00 p.m. |
Trending QSR Data: Requirements and Best Practices for Devicemakers Attendees will learn:
James Eric Miller, Senior Quality Analyst, Core Quality Systems, Roche Diagnostics |
12:00 p.m. – 12:45 p.m. |
Integrating End Use Communities into Device Design Workflow Attendees will learn:
Krishna Uppugonduri, Vice President, Quality and Regulatory Affairs, CareFusion |
12:45 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:15 p.m. |
Morning Recap by Co-chair Elaine Messa |
2:15 p.m. – 3:00 p.m. |
CDRH’s Compliance and Enforcement Outlook Attendees will learn:
Larry Spears, Deputy Director for Regulatory Affairs, CDRH, FDA |
3:00 p.m. – 3:45 p.m. |
Best Practices in FDA 483 and Warning Letter Management and Recovery Attendees will learn:
Elaine Messa, Director, Medical Device Quality Systems and Compliance Practice, Becker & Associates Consulting, Inc. |
3:45 p.m. – 4:00 p.m. |
Refreshment Break |
4:00 p.m. – 6:00 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: Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding Panelists:
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6:00 p.m. – 7:30 p.m. |
Adjournment and Networking Reception |
DAY THREE: THURSDAY, JUNE 9, 2011 |
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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. |
FDA Postmarket Surveillance Program: Where we have been… where we are going? Attendees will learn:
Isaac Chang, Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH, FDA |
10:00 a.m. – 10:45 p.m. |
Recall Management: Analyzing Recent High-Profile Recalls and Lessons Learned Attendees will learn:
Mark Brown, Partner, FDA & Life Sciences Practice, King & Spalding; Former Associate Chief Counsel, FDA |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 a.m. |
Closing Keynote: CDRH's Business Case for Compliance Attendees will learn:
Steven Silverman, Director, Office of Compliance, CDRH, FDA |
11:45 a.m. – 12:00 p.m. |
Closing Comments by Co-chairs Steven Niedelman and Elaine Messa |
12:00 p.m. |
Conference Adjournment |