F3: Strategies for Auditing in the Global Pharmaceutical Regulatory Environment - Joseph Knight McKenna –(All)

Even though there has been significant advancement in harmonization of global pharmaceuticals regulations, unique local requirements still exist for most countries. The risks of non-compliance with regulations increases with the more countries products are marketed and the more locations clinical trials are performed. To reduce these risks, companies must be diligent in their regulatory knowledge to ensure their processes are comprehensive for all regulatory agencies in which they do business. Auditors in this environment must also have an extensive understanding of all regulations and guidances to be able to provide meaningful audit reports to their employer or clients.

The presentation will look at both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) and the challenges that face an auditor in a multinational pharmaceutical organization. Strategies will be discussed that pharmaceutical businesses and auditors can use to be successful in the global regulatory environment