Course offering number:0810-705
Course ID:
2227
Assuring Your Supply Chain through Supplier Qualification
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Irwin Silverstein, President, IBS Consulting in Quality, LLC
Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in quality assurance for the API, medical device, and drug products areas.
He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked for over 17 years with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented the organization at various conferences and at the Food & Drug Administration. Of note, Dr. Silverstein is the technical consultant to IPEC for the development of their Excipient Qualification guide and assisted in the matter of Supply Chain Security for ingredients.
In addition to working as a consultant to the industry, he is the Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA). As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as an ISO 9000 Certified Lead Auditor status, he has developed the IPEA auditor-training program and has trained their auditors. He is the co-instructor of the IPEA Excipient GMP Audit Workshop. Recently, his consulting work has included pharmaceutical firms under FDA Consent Decree. Also he has audited excipient manufacturers to perform a gap analysis with respect to excipient GMP compliance and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements.
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