ComplianceOnline, online event
18 February 2021
DAY 01(10:00 AM - 4:00 PM EDT) - Introduction (15 mins)
- Session 1
- Complaint Handling and FDA Expectations (90 mins)
- Break (15 mins)
- Session 2
- Continuation Complaint Handling and FDA Expectations (30 mins)
- Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
- Lunch Break (45 mins)
- Session 3
- Continuation of Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
- MDR reporting by firm, agents Voluntary Malfunction Summary Reporting (VMSR) and eMDR Discussion (30 min)
- Break (15 mins)
- Session 4
- Guidance Documents Update (30mins)
- Being Recall Ready (30mins)
- Questions and Recap (10 mins)
DAY 02(10:00 AM - 4:00 PM EDT) - Session 1
- Recalls, Definition and Legal Authority Overview (60 mins)
- Corrective and Preventative Actions (CAPA) (30 mins)
- Break (15 mins)
- Session 2
- Health Hazard Evaluations HHE/HRA (30 mins)
- Elements of a Correction and Removal -- 806 Reporting (45 mins)
- Lunch Break (45 mins)
- Session 3
- Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)
- Notifications Letters and Press Releases (20 mins)
- Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)
- Break (10 mins)
- Session 4
- Product Retrieval (20 mins)
- Status Reports (20 mins)
- Effectiveness Checks Follow-up Planning (20 mins)
- Terminating a Recall (15 mins)
- Wrap-up (5 mins)
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Invited Speakers:
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Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products. Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.
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