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FDA Recalls - Before You Start, and After You Finish: 2-Day In-Person Seminar by Ex-FDA Official

ComplianceOnline

Thursday, February 9, 2017 at 8:30 AM - Friday, February 10, 2017 at 4:30 PM (PST)

FDA Recalls - Before You Start, and After You Finish:...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird price)
Registrations after January 20, 2017 - $1899
Feb 9, 2017 $1,599.00 $0.00
Seminar One Registration Feb 9, 2017 $1,899.00 $0.00

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Event Details

Course Description:

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.

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:

  • Manufacturers
  • Own Label Distributors
  • Importers
  • Healthcare institutions
  • Nursing homes
  • Medical practice groups

 

For Registrationhttp://www.complianceonline.com/fda-recall-program-training-workshop-seminar-training-80331SEM-prdsm?channel=eventbrite          

 

Note: Use coupon code < NB5SQH8N > and get 10% off on registration.

Have questions about FDA Recalls - Before You Start, and After You Finish: 2-Day In-Person Seminar by Ex-FDA Official? Contact ComplianceOnline

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When & Where


San Jose

San Jose, CA

Thursday, February 9, 2017 at 8:30 AM - Friday, February 10, 2017 at 4:30 PM (PST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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FDA Recalls - Before You Start, and After You Finish: 2-Day In-Person Seminar by Ex-FDA Official
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