Synopsis

This one day seminar is aimed at QA staff in drug products manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC. QPs are required to declare that the active materials used in each of their products have been manufactured to GMP as interpreted by the EU. Participants will learn about the legislators’ perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers.

The seminar includes:
> the background to current GMPs for APIs
> FDA and EU interpretation of GMPs for APIs
> specific opportunities from the guidelines that API manufacturers may exploit
> specifics of what to look for when auditing an API site.

Who should attend
> Supplier auditors for drug products manufacturers
> QPs in manufacture of drug products
> QA managers who support the QP / declaration
> QC managers of drug products manufacturers
> Production managers of drug products manufacturers

Course Speaker

Dr David Inglis is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs. He has a Ph.D. degree in enzyme chemistry (affinity chromatography).

During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits.

Dr Inglis is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.