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GMP Auditing for Pharmaceutical Manufacturing

Duration : 60 Minutes

Carl Patterson, MS, SSGB, SSBB,

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However Read more

Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality, as well as,  in the management of outsourced activities and purchased materials.

Course Objective:

• Understand the GMP context for pharmaceutical quality system lead auditors
• Plan, conduct, report and follow-up an audit of a GMP PQS
• Provide guidance for auditors of suppliers, contractors, CMO service providers, outsourced activities and self-inspectors
• Drive continuous improvement of systems and processes
• Drive continuous improvement of auditors and audit systems

Course Outline:

Principles and Audit Planning

• Planning and preparation
• Audit types and techniques
• Internal vs. external audits
• The audit process

Auditor Skills and Competencies

• What makes a good auditor
• Managing audits

Initiating, Preparing and Conducting the Audit

• Materials management
• Documentation systems
• Pharmaceutical quality systems

What You Get:

• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance
• Logistics
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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