Expert Profile
Marie Morin
President, MFM GMP Consulting
Marie Morin is an experienced former US FDA Drug Specialist with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including: China, India, Germany, Italy, Austria, Ireland, France and the Netherlands to name a few. Now working as a consultant to help those in the Pharma industry be more comfortable with the FDA and help them be prepared for FDA inspections and expectations.
She is skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API's and Finished products, Good Laboratory Practice (GLP) Lab facilities, Biologically produced API and finished products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to: Change Control, Deviations, Complaints, Investigations and CAPA as well as laboratory documents and raw data as well as OOS investigations. Well versed in Biotechnology, and Regulatory Requirements.
A strong business development professional with a BS focused in Health Sciences w/ 50 hr Microbiology concentration from East Tennessee State University.
Trainings by Expert
How to undergo an FDA Inspection Successfully
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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Clinical Research
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Biotechnology
,
Laboratory Compliance
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All FDA Regulated Industry
,
FDA Audit and Inspection
,
Documentation and IT
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
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Supply Chain and Manufacturing
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R & D
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Laboratory
,
GLP & Other Best practices
,
Microbiology Laboratory
,
Clinical Laboratory
,
Analytical Laboratory
,
GCP & Other Best Practices
,
Food & Dietary Supplements
,
Manufacturing & Contamination control
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Audit & Inspection-Role
,
Internal Audit
,
Food Safety Audit
,
All FDA Reg. based Audit
,
Medical Device Inspection
,
Lab Audit
,
Drugs Inspections
,
Clinical Research Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Food Safety & Quality
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Device R & D
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
Common FDA Regulations
,
QA/QC
