This intensive course is offered publicly in Europe, Asia/Pacific and N. America and in-company anywhere in the world. Typical attendees are (1) experienced auditors from the pharma-industry who wish to become Registered EXCiPACT Auditors, (2) Suppliers preparing for a Certification Audit and (3) Users wanting to understand the scope and content of an EXCiPACT audit for supplier qualification and regulatory purposes.
Auditors wishing to become EXCiPACT Registered must attend this course and gain a 70%+ pass exam mark. They must also have prior significant knowledge of Quality System Management (ISO 9001:2015), as well as experience within the excipient and/or chemical industry.
The course content includes: GMP & GDP for Pharmaceutical Excipients; EXCiPACT & Certification of Excipient Suppliers; The EXCiPACT Certification Auditor; Good Manufacturing Practices for Pharmaceutical Excipients; Quality Documentation; Excipient Supplier Certification; The Certification audit realisation in practice; and the Exam for auditor qualification.