This training course will be on 29 March-1 April 2021, from 13:30h–17:30h each day Brussels CET time (= 07.30h–11.30h EST USA) at a cost of €1500 per person (or USD 1842 per person). There are only 10 seats available to be filled on a first-to-pay basis.
This intensive course is offered publicly in Europe, Asia/Pacific and N. America and in-company anywhere in the world.
Typical attendees are:
- Experienced Auditors who are already familiar with the Pharmaceutical Quality requirements who wish to become Registered EXCiPACT Auditors;
- Quality System Auditors (e.g.ISO-9001) who want to acquire a detailed knowledge about Excipient Good Manufacturing Practices and Good Distribution Practices;
- Manufacturers and Distributors of Excipients preparing for a Certification Audit;
- Quality representatives of excipient suppliers who want to get practices for performing internal quality audits in their organisation; and
- Users of Excipients wanting to be able to manage second parties’ audits of their suppliers, and 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:
- Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for pharmaceutical excipients;
- Pharmaceutical regulation requirements for excipient suppliers and excipient customers;
- EXCiPACT certification and registration of excipient suppliers;
- EXCiPACT certification and registration of auditors;
- EXCiPACT certification validation by the auditor;
- The management of quality audits by the auditor, auditing practices, and certification audit procedure;
- Classification of audit observations (critical, major, etc..), sharing of audit experiences; and
- Exam for auditor qualification.
Should you cancel your registration, no refund will be given but you may transfer your place to a colleague from the same company.
By registering for the event, it is assumed that you accept these booking conditions.
Download registration form
Location: Remote connection