GMP Audits: Tools and Techniques
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.
The extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas where improvements are needed.
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 personnel.
- 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
Course Level - Intermediate
Who Should Attend
- Quality Assurance
- Quality Control
- Quality system auditors
- QA directors and managers
- Regulatory and Compliance Management