Hosted by Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL 60015
This workshop will focus on excipient GMP compliance and attendees will learn auditing techniques, report writing, and observation classification skills that relate to the manufacture of excipient ingredients. The workshop contains exercises to hone observation skills including participation in a hands-on mock excipient GMP audit. Participants will gain a thorough understanding of risk-based excipient auditing and learn how to assess whether an excipient GMP quality system can achieve a satisfactory level of compliance. Finally, attendees will learn how to differentiate the requirements for excipient manufacture from those of APIs. Hear the latest concerning Excipient GMP Conformance Certification.
Participants who complete the course will have learned how to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP standards as listed in <1078> of USP/NF and in IPEC GMP Guidance.
- Traditional and biologic pharmaceutical and nutritional supplement manufacturing personnel whose duties involve the assessment of excipient supplier practices (such as pharmaceutical ingredient auditors and others who conduct audits)
- Excipient producers and distributors (to effectively audit their own operations and anticipate the expectations of customers)
- Anyone involved in conducting or hosting excipient audits
- Anyone involved in excipient quality assurance, regulatory affairs, and supply chain integrity
After completing this hands-on, interactive workshop:
- All participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP expectations.
- Excipient makers will be able to assess their conformance to NSF/IPEC/ANSI 363 and remediate any gaps.
- Excipient users will be able to:
- assess their suppliers for adequate conformance to NSF/IPEC/ANSI 363.
- address the EU Falsified Medicines Directive (FMD) Guideline on the formalized risk assessment for determining the appropriate good manufacturing practice for excipients of medicinal products for human use.
- Assessing GMPs for Excipient Manufacture
- Where GMPs Begin
- Audit Planning
- Pre-audit Questionnaires
- Alternative Audit Approaches
- Audit Checklists & Techniques
- Necessary Auditing Interpersonal Skills
- Defining Pertinent Audit Issues In Observations
- Writing & Rating Observations
- Excipient Manufacture Requirements vs. APIs
- Review of NSF/IPEC/ANSI-363 Excipient GMP Standard
- Hands-On Mock GMP Audit
Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked since 1991 with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His recent consulting has broadened to include pharmaceutical firms where he assesses conformance to site requirements. 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. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin is also serving as leader of the IPEC-Americas Excipient Learning Lab (ELL).
Sidney A. Goode Pharm D, RPh worked with Dow Chemical for thirty eight years, holding positions in chemical and toxicology research, product regulatory management, sales/marketing, FDA regulatory compliance management, quality and project management. He was also part of a team that supported the approval of products seeking regulatory acceptance for marketing; a member of the consolidated audit group qualifying and auditing suppliers, quality systems and regulatory compliance with industry standards. His career spanned intervals in the areas of industrial hygiene, medical department administration and environmental compliance. A decade was spent working part time as a co-director of a psychiatric hospital pharmacy participating in clinical trials of potential drugs and treatment regimens.
He is currently working as a consultant concentrating in areas of regulatory and quality compliance in the pharmaceutical, food and associated industries. His activities also include auditing work with International Pharmaceutical Excipient Auditing, IPEA Inc. (now operated by NSF International), and educational training through IPEC-Americas newly organized training committee. His training includes a BS degree in Biology/Chemistry, BS, Pharm D in Pharmacy, and certification in Clinical Toxicology. He has worked with International Pharmaceutical Excipient Council, IPEC, from early formation in the creation and publications of GMP and supporting guidance documents. He has held positions on the Board of Directors, and was chair of the GMP Committee for several terms.