If you’re sitting back waiting for an audit by the U.S. Food and Drug Administration (FDA), you’re making a huge mistake. Pharmaceutical manufacturers must proactively perform internal Good Manufacturing Practices (GMP) audits to uncover and correct noncompliance areas. Still, there problems with this approach, particularly when internal auditors aren’t fully trained in the regs or audit techniques—or when they are conflicted about pointing out errors their coworkers and friends have made.
Join pharmaceutical manufacturing expert Carl Patterson as he walks you through how the FDA and other regulators have contributed to and endorsed the ICH Q10 Pharmaceutical Quality System (PQS)—which explicitly recommends audits as a key element in reviewing process performance and product quality. Self-audits also help you manage outsourced activities and purchased materials. Learn how an internal audit can improve on your GMP processes and—most importantly—enable you to catch issues before an FDA inspector does!
After attending this audio event, you will be equipped to spot potential problems and execute a remedial plan—all before a regulatory inspector knocks at your door. When the FDA does arrive, you’ll give the inspector an immediate sense that your company knows its GMP process.
Get the knowledge, understanding, skills, and confidence to audit all aspects of pharmaceutical manufacture and control, all while retaining the cooperation and respect of other auditors and fellow staff.
This program will teach you how to:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
Carl Patterson, M.S., 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...
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