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.
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.
attending this webinar participants will:
the GMP context for pharmaceutical quality system lead auditors
conduct, report and follow-up an audit of a GMP PQS
guidance for auditors of suppliers, contractors, CMO service providers,
outsourced activities and self-inspectors
continuous improvement of systems and processes
continuous improvement of auditors and audit systems
should you attend?
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.
Auditor in Pharma companies
good manufacturing practices
- pharmaceutical regulations compliance
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.