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| Instructor Profile |
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Peter Calcott
President,
Calcott Consulting
FDA Audit and Inspection
Ph.D. is the President of Calcott Consulting, a consulting firm focused on supply chain, quality, clinical development, regulatory affairs and corporate compliance. He has over 30 years experience in the industry having positions in Quality, manufacturing, process development, compliance. He has worked for large Pharma as well as small biotechnology companies. He has licensed and introduced new products to the marketplace on 6 continents.
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| Trainings By Peter Calcott |
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Process Validation, planning, strategy, requirements, risk assessment, design description
Category:
FDA Compliance
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FDA Validation
How to prepare for the unannounced FDA compliance inspection
Category:
FDA Audit and Inspection
Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect
Category:
FDA Compliance
,
FDA Audit and Inspection
Preparing for FDA Pre-Approval Inspections
Category:
FDA Compliance
,
FDA Audit and Inspection
Surprise FDA GMP inspection - how to prepare for it
Category:
FDA Audit and Inspection
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