Understanding and Preparing for FDA Pharmaceutical Inspections


Instructor: Michael Ferrante
Product ID: 706965

  • 25
  • June 2024
  • 10:00 AM PT | 01:00 PM ET
    Duration: 90 min
This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

June 25, Tuesday 10:00 AM PT | 01:00 PM ET
Duration: 90 min


One Dial-in One Attendee

Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)



1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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
Instructor Profile:
Michael Ferrante

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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