Effective Pharmaceutical GMP Audits and Self-Inspections
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 and also in the management of outsourced activities and purchased materials.
Course Objectives:
• 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
Why Should You Attend:
Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as "telling on" the friend and possibly causing a problem for them.
This webinar will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the other auditors.
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 our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This course is designed for auditors assessing:
• New QA personnel involved with auditing for virtual companies
• Personnel introduced to auditing
• Subject matter experts
• Who may accompany QA personnel and/or conduct audits
• Management personnel who wish to understand the auditing process
• Contract manufacturing organizations
• API suppliers
• Excipient suppliers
• Packing component suppliers
• Service providers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
