MDPharmaCourses | Regulatory, Quality and Compliance Training

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

€225.00

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Description

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

DURATION:

1 h + 10 min. Question Time

Write to info@tsquality.ch to define a suitable timeframe for getting the course 

Description:

 

Areas Covered in the seminar

  • Documents Used by FDA Inspectors
  • Operations Manual (IOM)
    • CAPA Implications, by Section
      • Requirements
      • Recommended Methods of Compliance for Each Requirement
  • CPG Manual 7382.845
    • CAPA Implications, by Section
      • Requirements
      • Recommended Methods of Compliance for Each Requirement
  • QSIT Manual
    • Description/explanation of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

 

LEVEL: INTERMEDIATE

Why You Should attend

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to an FDA-regulated manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. The best way to assure compliance is to be well versed in the method of questioning used by the FDA inspector, and prepare accordingly.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

 

 

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
CAPA Coordinators
Executive Management
R&D Management
Regulatory management
QA management
Consultants
Quality system auditors

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

 

Online Training Programs Includes:

  • Answer to questions submitted during the webinar.
  • An online final assessment with multiple choice questions.
  • A Certificate of Completion.

 

Live Course Presented and Commented by:

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.

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