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David Inglis, Ph.D. |
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David Inglis, Ph.D.Lancaster, England
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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