What to expect from the US FDA and other external inspections/audits. How to conduct internal and supplier/vendor audits. Factor the US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.
Each year, U.S. FDA regulatory inspections get tougher. This is certainly true of clinical trial expectations. Improvement in a sponsor's internal Good Clinical Practice audit program can greatly facilitate addressing this increased emphasis. This webinar will look at basic areas of emphasis. Also, these areas of focus have a major impact on individual compliance objectives, efforts, and measurements of success. Pre-, during-, and post audit considerations. We will further evaluate the chief areas of regulatory concern and evaluate the actual and anticipated changes in emphasis, and how to better prepare to proactively locate actual and potential areas of concern in GCP compliance with a sponsor's supplemental internal audit program. The focus is on participant information and safety, accuracy of data, and adherence to pre-approved protocols by all participants/stakeholders.
In drug (and device development and production, good clinical practice (GCP) is an international quality standard, for clinical trials involving human subjects. GCP follows the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), with a focus on the ethical aspects of clinical research.
High standards are required in comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. On-going QA and inspections / audits ensure adherence to these standards. The GCPs ensure that the studies are scientifically/ statistically based and potential clinical problems are found and addressed before compromising the trial.
This webinar will provide test scripts and rationale for a "model" for internal /self-audits. It will describe a "typical" GCP inspection, how to replicate with your internal audit. The Notification, the Agenda / Audit Plan, daily reporting, Draft Final Report, Formal Final Report. Templates / examples. The clinical / GCP internal audit as a training tools.
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.