What are On Site Training Courses?
On Site Training Courses are an ideal solution and a cost-effective way to train many staff members (typically up to 20) for the same price. Experienced and knowledgeable trainers will come to your facility (or designated location) at a time and date to suit your schedule.
Compare 3-day workshop fees for off-site and on-site:
Off site: $1,850 IPEC-Americas members company employees / $2,250 Non members
On site: $19,900 for up to 20 member company participants / $22,500 Non members
(Savings of up to $1125 per participant!)
Read article Why is GMP Training a Necessity at Excipient Sites? by IPEC-Americas Lead Trainer, Irwin B. Silverstein , Ph.D.
On Site training offers:
- Requirements of ISO 9001, EXCiPACT ISO 9001 GMP and GDP Annexes, and ANSI NSF/IPEC/ANSI 363 Excipient GMP Standards
- Excipient GMP (NSF/IPEC/ANSI 363-2014) Compliance for Auditors and Auditees
- Excipient Quality Risk Management and Risk Assessment
- Quality by Design for Excipients
- Customized workshops for pharmaceutical users: supplier qualification
Or propose a topic that is critical to your business!
IPEC-Americas presenters and trainers are:
- Subject Matter Experts → Years of experience in excipients
- Active IPEC-Americas Members → Well-informed on the most up-to-date issues affecting excipients
- Experienced Presenters/Trainers → Providing professional, engaging content delivery and interaction.
Instructors have intimate knowledge of excipient manufacturing, experience in the development of the IPEC guidelines, and individually have more than 20 years of experience in training auditors and employees at excipient manufacturing companies.
On-site Excipient GMP Auditing Workshop (2-3 days)
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 USP/NF General Information Chapter <1078> and in the IPEC-PQG Excipient GMP Guide.
On-site GMP Training (1-2 days)
Content can be tailored to include:
- U.S. FDA regulations and expectations for excipients
- Excipient GMPs
- Requirements of ISO 9001, EXCiPACT ISO 9001 GMP and GDP Annexes, and ANSI NSF/IPEC 363 Excipient GMP
- Good Documentation Practices
- Importance of following procedures and reporting deviations
- Corrective and preventive actions (CAPAs), and close out
- Investigation of OOS and OOT results.
- Investigation of customer complaints, and close out
- Impact of worker performance on patient safety.
Have a different excipient related topic in mind? Let us know.
Contact us now to request a training proposal. We will arrange the training for you based on the scope of your company’s specific needs.
Excipient Learning Lab