Internal GMP Audit Program - Execution and Communication

Speaker

Instructor: Ronald Torlini
Product ID: 705750
Training Level: Basic to Advanced

Location
  • Duration: 60 Min
This webinar will discuss the steps to execute internal GMP Audit, how to get all departments for acceptance and how to communicate audit findings specifically when it is serious and quality needs confirmation of acceptance and resolution.
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Why Should You Attend:

Regulations and agency expectations need to be met for an Internal GMP audit program. The set-up of such a program starts with senior management approval and many face to face meetings with various departments that will be audited. The “What’s In It For Me” (WIFM) has to be explained to the various other departments for acceptance.

This webinar will discuss the regulation surrounding internal audits and the establishment of the system. How to conduct internal GMP audit step by step and highlight how to review findings, how to communicate and close out where findings could be serious and Quality needs confirmation of acceptance and resolution.

Areas Covered in the Webinar:

  • Management Approval of the Program
  • Set a Schedule and Follow It
  • Audit Plan
  • Communication of Findings
  • Close out Meeting
  • Report and Follow-Up and Tracking
  • SOP Internal GMP Audit
  • FDA Inspections and Exhibits

Who Will Benefit:

  • Quality Professionals
  • Manufacturing Personnel
  • Auditors
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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