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Preparation for FDA and EU Regulatory Inspections – 2018 Workshop
This Webinar is over| Date | Sep 27, 2018 |
| Time | 11:00 PM EDT |
| Cost | $80520.00 |
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Online
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The seminar will be interactive, to allow delegates to discuss examples from their own inspection experience, and will also include practical exercises in making presentations to inspectors and compiling inspection responses.
Learning Objectives:
Learning Objectives:
- Gain understanding of the legislation behind regulatory inspections and the different types of inspection
- Understand the requirements for an effective Quality Management System
- Gain understanding of what inspectors are looking for during an inspection
- Learn how to prepare for a scheduled inspection
- Understand what to look for in a pre-audit self-inspection
- Identify pitfalls and errors during an inspection
- Understand what to say, how to say it, what you should NOT say
- Learn how to respond to deficiencies during an inspection and the follow-up CAPA
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Regulatory Affairs Departments
- Research and Development Departments
- API Manufacturers
- Production Departments
- Documentation Departments
- Warehousing
- Supply Chain / Outsourcing
- Contract Manufacturing Organizations
- Contract Testing Laboratories
- Internal Auditors
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