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Effective Pharmaceutical GMP Audits and Self-Inspections

: 7 Jun 2018

Sector: Clinical, Pharmaceutical

Type: Webinar

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.

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.

Principles and Audit Planning:
• Planning and preparation
• Audit types and techniques
• Internal vs. external audits
• The audit process
Initiating, Preparing and Conducting the Audit:
• Materials management
• Documentation systems
• Pharmaceutical quality systems

• 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

This course is designed for auditors assessing:
• Contract manufacturing organizations
• API suppliers
• Excipient suppliers
• Packing component suppliers
• Service providers

For more detail please click on this below link:



Training Doyens
Phone: +1-720-996-1616
Visit: https://www.trainingdoyens.com

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