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 You Should 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.
Areas Covered in the Session :
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
Who Should Attend:
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