Win-Win FDA Inspections
Instructor:
James Harris(PhD)
Product ID: 701482
Training Level: Intermediate to Advanced
- Duration: 70 Min
Why Should You Attend:
We know when some GMP inspections such as Pre-approval inspections, will be conducted. However most such inspections come completely by surprise. Because of this, a system for hosting an inspection team and monitoring its activities must be established in advance of an inspection. This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. In addition, key inspection topics that are the current "hot buttons" for FDA will be reviewed and approaches that will keep these points off your FD 483 will be identified.
A successful FDA inspection requires preparation including pre-assigning the personnel who will be involved, training them, and having dress rehearsals so that all activities on the part of the manufacturer's personnel is performed correctly and naturally. This webinar presents the information needed to prepare for an inspection and will discuss some of the more critical points with suggestions as to how they should be handled.
Areas Covered in the seminar:- How many company personnel should be prepared and what duties should each team member have.
- How to greet the FDA inspector(s).
- Basic rules for conducting the inspection.
- Instructions for non-team members.
- In-house communications.
- The FD-483.
- Post inspection requirements.
Who Will Benefit:
- QA & QC managers and staff members
- Manufacturing managers and staff
- Senior corporate managers
- Technical services
- Engineering managers and staff
Instructor Profile:
James R. Harris, PhD held VP level management positions in several of the world's largest pharmaceutical firms before forming a consulting organization that worked globally serving pharmaceutical and related industries in over 60 countries.
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