How to Prepare for Regulatory Inspections conducted by FDA, EMA, MHRA, and PIC/S скачать в хорошем качестве

How to Prepare for Regulatory Inspections conducted by FDA, EMA, MHRA, and PIC/S

Regulatory inspections can be a source of uncertainty for many organizations. This webinar will give you an insight into what to expect during a regulatory inspection. The differences in the approach taken by three of the main regulatory authorities and PIC/S, as the co-operative body of 56 Regulatory Authorities, are explored in detail. Whilst some differences still remain, it is clear that the focus on Quality Culture and Quality Management Maturity is common. Join NSF experts Dr. Lynne Ensor, Dr. Pete Gough, Dr. Samantha Atkinson, Dr. Julia Marré, and Kay Hukin as they look at regulatory inspections by regulatory authority. Our speakers are all ex-regulators or acknowledged industry experts. Dr. Lynne Ensor and Dr. Julia Marré have both spent considerable time working for the US FDA. Dr. Samantha Atkinson worked for many years at the UK's MHRA. Dr. Pete Gough and Dr. Kay Hukin both have extensive experience in the pharmaceutical industry gained over many years.