External GMP Audits for Pharma Companies

Instructor: Ronald Torlini
Product ID: 705761
Training Level: Basic to Intermediate
  • Duration: 60 Min
This GMP audit webinar will discuss the importance of external GMP audit, FDA requirements, best practices and steps for external audit execution, reporting, follow up and quality agreements between company and its suppliers/contractors.
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Read Frequently Asked Questions

Why Should You Attend:

Part of any Quality system program is the conducting of External GMP audits. The FDA and other agencies focus on the firms’ External audit programs for suppliers and contractors. An External audit program allows assessment of risk with contractors and suppliers that are used for drug product final release. The program should show how these suppliers and contractors are managed.

In this session, Mr. Torlini will provide the elements of setting up an External Audit program and the FDA expectations for External Auditing. He will also discuss the need to have R&D and Supply Chain involve with the program. It will also provide guidance on final Quality Agreement that should be in place to capture the responsibilities of both firms.

Areas Covered in the Webinar:

  • Roles & Responsibilities of Quality, R&D and Supply Chain
  • Types of Audits
  • Audit Plan
  • Legal requirements for third party audits (for example: suppliers, contract manufacturing organizations, etc.)
  • How to set up a yearly audit schedule
  • Audit tools/techniques
  • Execution of the Audit
  • Reporting of the Findings
  • Follow Up Activities
  • Quality Agreements

Who Will Benefit:

  • Quality Professionals
  • R&D Groups
  • Supply Chain Groups
Instructor Profile:
Ronald Torlini

Ronald Torlini
Principal Consultant, RP Torlini Consulting LLC

Ron Torlini of RP Torlini Consulting has over 30 years of pharmaceutical experience in SQM, CQM, systems, compliance and regulatory areas. He has worked for such companies as Sterling Drug, Sandoz, DuPont Merck, J&J and others.

His experience has been hands-on at site level and establishing corporate policy at the corporate levels.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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