2018 - Effective Pharmaceutical GMP Audits and Self-Inspections

OVERVIEW
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.
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.
AREAS COVERED
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
LEARNING 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
WHO WILL BENEFIT
This course is designed for auditors assessing:
• Contract manufacturing organizations
• API suppliers
• Excipient suppliers
• Packing component suppliers
• Service providers
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