FDA Pre-Approval Inspections

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Jan 28, 2008 End Date/Time: Jan 29, 2008
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Description

An Important Two-Day Comprehensive & Interactive Seminar with Case Studies and Workshops On:

- FDA, Today and Tomorrow
- FDA Rules and Regulations
- FDA’s Initiative on Pharmaceutical cGMPs for the 21st Century
- Application and Approval in the US
- FDA Inspections
- FDA Pre-Approval Inspectional Program Before, During and After
- System Based Inspections Quality, Facility & Equipment, Materials, Production, Packaging/Labeling, Lab Controls
- A Quality Systems Approach to GMPs
- Most Common GMP Deficiencies by Systems
- Expectations for cGMPs for Laboratories
- Inspections of Combination Devices
- Requirements for Inspection Preparations
- Surviving an US FDA Audit
- Criteria for Warning Letter vs Violation Letter
- Responding to FDA FD-483

Distinguished Course Leaders

Ms. Maxine Fritz
Vice President, Pharmaceutical Quality Systems and Validation
Quintiles Consulting

Mr. John Godshalk
Senior Consultant
Biologics Consulting Group

Dr. Marla Phillips
Senior Compliance Consultant
IHL Consulting Group, Inc.

Venue

Toronto
Toronto
Ontario
Canada
MORE INFO ON THIS VENUE

Additional Information

Registration Information: Multiple Registrations: Send five attendees and the sixth is FREE! Early Bird Discount: Register early. Payments received by December 1, 2007 will be given a 10% discount. 25% Discount - for Health Canada and Government Employees, Full Time Students & Academic Faculty

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