How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation
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How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation
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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
- CAPA Implications, by Section
- CPG Manual 7382.845
- CAPA Implications, by Section
- Requirements
- Recommended Methods of Compliance for Each Requirement
- CAPA Implications, by Section
- QSIT Manual
- Description/explanation of each CAPA Inspectional Objective
- Recommended Methods of Compliance
LEVEL: INTERMEDIATE
Why You Should attend
Who Will Benefit:
- 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.
