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

SPEAKER

Years of Experience: 29+ years

Areas of Expertise: Biology, Microbiology, and Biochemistry

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, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

Carl holds various degrees and certifications, includingan M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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