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      FDA Recalls - Before You Start, and After You Finish in Daly City

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      March 26, 2020

      Thursday   8:30 AM - 4:30 PM (daily for 2 times)

      Daly City, California 94016

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      FDA Recalls - Before You Start, and After You Finish

      FDA Recalls - Before You Start, and After You Finish
      About this Event

      FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it."

      Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.

      You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.

      Seminar Fee Includes:LunchAM-PM Tea/CoffeeSeminar MaterialUSB with seminar presentationHard copy of presentationAttendance Certificate$100 Gift Cert for next seminar

      Learning Objectives:

      Understand FDA's recall authority and policy
      Learn how to manage recalls under FDA oversight
      Learn how to interact with FDA
      See how to develop health risk determinations
      Learn critical recall strategy components
      Manage possible FDA enforcement actions
      Who will Benefit:

      Recall managers
      Quality assurance managers
      Regulatory affairs directors
      Risk and product liability managers
      Manufacturers’ sales and marketing managers
      Own label distributors
      Companies and departments:

      Own Label Distributors
      Healthcare institutions
      Nursing homes
      Medical practice groups
      Topic Background:

      The products regulated by the FDA can cause serious adverse health consequences or death. The FDA's recall program is designed to make sure firms' recalls can mitigate such problems, even when the adverse consequence seems remote. The FDA's recall program has remained relatively the same over several years. How the FDA and industry manage recalls and learn from their mistakes continues to evolve. In some ways recalls have become more efficient through the benefit of technology. In other ways the reason for recalls remains substantially the same. The FDA's recall procedures and regulatory management of any risk to health are still sufficient to determine whether a recall is effective and whether manufacturers learn from their mistakes.


      DAY 01(8:30 AM - 4:30 PM)

      08.30 AM - 09.00 AM: Registration

      09.00 AM: Session Start

      Day 1 - Morning

      FDA’s Regulatory Authority

      Recall Regulations

      Voluntary recall: 21 Code of Federal Regulations (C.F.R.) Part 7

      Mandatory recall actions

      21 C.F.R. Part 810

      21 C.F.R. Part 806

      Recall Classification

      Violation of the law

      Break (10:30 a.m. – 10:45 a.m.)

      Risk to Health



      Stock Recovery

      Product Withdrawal

      Product Improvement

      Lunch (12:00 p.m. to 1:00 p.m.)

      Day 1 / Afternoon

      Recalls and risk to health

      Risk to health categories


      Serious injury / serious illness

      Non-reversible / reversible

      May cause, if it were to recur

      Remote possibility

      Break (2:30 p.m. – 2:45 p.m.)

      Health Hazard Evaluation for Recall Classification

      FDA’s internal evaluation

      Vulnerable subpopulations



      Industry HHE equivalent

      FDA’s recall database

      DAY 02(8:30 AM - 4:30 PM)

      Day 2 - Morning

      FDA’s Recall Procedures

      Understanding FDA’s program and implementation

      FDA’s agency-wide recall procedures

      The FDA’s investigator’s job

      Preparing a recall strategy

      Break (10:30 a.m. – 10:45 a.m.)

      Preparing for FDA oversight

      Recall notification to FDA’s District Office

      Recall notification to the public

      Lunch (12:00 p.m. to 1:00 p.m.)

      Day 2 / Afternoon

      Root cause identification

      Correction and Prevent Action (CAPA)

      Break (2:30 p.m. – 2:45 p.m.)

      FDA inspectional follow up

      Enforcement: FDA administrative and legal remedies



      Casper (Cap) Uldriks

      Former Associate Center Director of FDA's CDRH

      Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

      Cost: $1,889

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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