Effective Pharmaceutical GMP Audits and Self-Inspections
Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
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, as well as, 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. 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 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.
Understand the GMP context for pharmaceutical quality system lead auditors
Principles and Audit Planning
• Planning and preparation
• Audit types and techniques
• Internal vs. external audits
• The audit processes
Auditor Skills and Competencies
• What makes a good auditor
• Managing audits
Initiating, Preparing, and Conducting the Audit
• Materials management
• Documentation systems
• Pharmaceutical quality systems
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 all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective. Furthermore, Carl holds various degrees and certifications, including an 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.