How To Conduct Internal Audit for GMP Compliance

Venue: Radisson Hotel Toronto East

Location: Toronto, Ontario, Canada

Event Date/Time: Aug 20, 2007 End Date/Time: Aug 21, 2007
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How To Conduct Internal Audit for GMP Compliance

Strategy and techniques on how to conduct effective interviews, analyze and interpret data, classify deficiencies, write reports to management and follow up on corrective actions.

A Two Day Interactive Training Seminar On

- Regulatory requirements - FDA, Canadian TPD, EU
- Audit mechanics
- Auditor training program
- Documentation - forms, checklists, reports, etc.
- Internal audit program - Self inspection
- Internal Facility Audits
- Internal audit: Product, process and system audits
- Use of checklists and templates as auditing tools
- Minor and Major Observations
- Preparation of Audit reports
- Decision making based on audit findings
- Audit follow-ups
- Implementation of corrective/improvement actions

Workshops on:
- Audit Program Preparation
- Quality Audit Checklists
- Laboratory Audits - Suspect Test Results and Deviation Documentation
- Preparation of Audit reports

Distinguished Course Leader

Mr. Angelo G. Scangas
Ms. Gabriela Bodea
Mr. Daniel S. Whelan
Mr. Ed Carey


55 Hallcrown Place

Additional Information

Who Should Attend: This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Medical Device, and allied industries with daily responsibilities in the following areas: Quality Assurance Documentation and Technical Writing Compliance Auditing Regulatory Affairs Change Control Quality Control Stability Validation Analytical Laboratories Regulatory Affairs Product Submission Training Manufacturing Consultants Contract Services GXPs Registration Fee: $795.00 + GST (6%) - Multiple Registrations: Send five attendees and the sixth is FREE!