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How to Manage Regulatory Inspections
Developing an Effective Response to
Regulatory Inspections (FDA and EU)
Conducted by David Inglis, Ph.D.
President - Ulverston GMP Consulting Ltd.
March 5, 2010
Developing an effective response to a regulatory inspection is a critical task that can often determine the future of your company. Dealing with regulatory agencies can be disruptive to your business. Hence, it is your best interest to develop a response that will satisfy the regulatory body and address any issues in a timely manner.
This web seminar will guide you through the steps so that you can create an effective response. Examples of thorough responses will be examined.
Part I - The Inspection Close Out Meeting
Part II - Purpose and Status of Regulatory Observations/Deficiencies
Part III - Immediately after the Inspection
Part IV - Structure of Response to Inspection Observations/Deficiencies
Part V - Making Changes Happen
Part VI - Questions and Answers
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GMP100305E - MP3 audio file and Handout materials
Developing an Effective Response to a Regulatory Inspection
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 higher degree (Ph.D.) in enzyme chemistry (affinity chromatography).
During more than three decades 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, and 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 in clinical trials and for medicinal products imported into the EU.
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 inspections.
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.
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