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. Our 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: $20,000 for up to 20 member company participants / $22,000 Non members
(Savings of up to $855 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 courses:
- Provide content that is tailored to suit your specific needs, and the needs of your staff.
- Can be delivered through interactive workshops, lectures, classroom learning, as well as customized site GMP gap assessments.
- Since these are private courses, there should be no concern for confidentiality
About Our Instructors
Our instructors are highly respected experts with knowledge and training that includes:
- Excipient GMP certification requirements,
- Excipient GMP auditing,
- Regulatory management,
- Quality systems and regulatory compliance with industry standards,
- Gap analysis with respect to excipient GMP compliance, and
- An appreciation for the concerns of the U.S FDA
Our 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.
Training and Education Services