Understanding and Preparing for FDA Pharmaceutical Inspections
Instructor:
Michael Ferrante
Product ID: 706965
- Duration: 90 min
Areas Covered in the Webinar:
FDA Inspectional Programs
Global Requirements for Regulatory Inspections
- FDA Inspectional Priorities
- Foreign Inspections
- FDA Enforcement Tools
Annual Trends in FDA 483 Observations
- How to Prepare for an FDA Inspections
- How to Develop a System of Constant Preparedness
Who Will Benefit:
- Pharmaceutical Professionals
- All levels of management
- Compliance management
- Regulatory Affairs Management
- API and Excipient Providers
- Manufacturing Professionals
- Service Providers
- Laboratory Professionals
- R&D Professionals
- Quality Professionals
Michael Ferrante
President, Quality and Compliance Associates LLC
Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.
During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, prepared and controlled compliance plans at both a site and corporate level. These interactions have occurred both domestically (US) and internationally, since he has dealt in global operations in countries such as Australia, Canada, the Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech Republic, India, China, Malaysia, and Thailand.
He has held middle to senior management positions in startup to Fortune 100 companies up to the level of VP of Quality Systems and Compliance. Mr. Ferrante has been asked to give presentations on a number of regulatory and quality topics by the American Society for Quality, the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and the Institute for Validation Technology. He has published articles in the Journal of Validation and Journal of Compliance.
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