Understanding FDA's Recall Authority and Policy

This course will teach 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." FDA's recall authority and program launches you into a project of crisis management.

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.

FDA Recall Training Agenda

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
Risk to Health
Precedents
Exemptions
Stock Recovery
Product Withdrawal
Product Improvement

Recalls and risk to health

Risk to health categories
Death
Serious injury / serious illness
Non-reversible / reversible
May cause, if it were to recur
Remote possibility
Health Hazard Evaluation for Recall Classification
FDA’s internal evaluation
Vulnerable subpopulations
Scoring
Participants
Industry HHE equivalent
FDA’s recall database

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
Preparing for FDA oversight
Recall notification to FDA’s District Office
Recall notification to the public
Root cause identification
Correction and Prevent Action (CAPA)

FDA inspectional follow up

Enforcement: FDA administrative and legal remedies

End

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
Many more....

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

.This live training Seminar includes the following for each registered attendee:

A copy of the presentation slides by download
A certificate of participation for attendee training records
Q/A Session
Free Handouts on FDA Inspection

How to Attend:

All WCS Seminar live training programs audio and visuals are delivered via Go to Seminar with a basic system requirement of a computer with internet access. You do not require a Go to Seminar account to join WCS Seminar live training courses, participants receive an email invitation that provides the access you need to join the meeting.

Know Your Faculty

Kelly Thomas, Head Of Quality Assurance (USA)

Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).

Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.

Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.

FDA Recalls - Before You Start, and After You Finish