Events

This training course, in English, will be held on 22nd and 23rd of January 2025, 2 days, from 09:00h to 18:00h each day at a cost of €1.815,00 per person.

This 2-day face-to-face intensive course is offered again and typical attendees are:

• Quality Assurance representatives from the Pharmaceutical Industry who want to audit their excipient suppliers with reference to state of the art Good Manufacturing and Good Distribution Practices for Pharmaceutical Excipients;
• Manufacturers and Distributors of Excipients who want to perform internal quality audit with reference to GMP and GDP for Excipients, or who want to be prepared for an EXCiPACT certification audit;
• Experienced auditors from the ISO-9001 perimeter who wish to become registered EXCiPACT auditors;
• Users who want 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 pass the final end-of-course exam. 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.

This interactive course includes many examples to be discussed, case studies and practical exercises. The main topics of the course are:

• Good Manufacturing Practices, Good Distribution Practices and Good Warehousing Practices for pharmaceutical excipients manufacturers and distributors;
• Comparision between EXCiPACT GMP, IPEC/PQG GMP, Chinese GMP for pharmaceutical excipients, and differences with ICH-Q7 GMP for Active Pharmaceutical Ingredients;
• EXCiPACT certification and registration scheme for excipient suppliers;
• EXCiPACT certification and registration of auditors;
• Quality Management System documentation and data integrity practices;
• Excipient supplier certification for Pharmaceutical users;
• Certification audit procedure in practice
• Exam for auditor qualification.

 

To register, please send the registration form (see download below) back to info@excipact.org. Your contact details will be treated according to our privacy policy. Successful registrants will receive an e-mail of confirmation once EXCiPACT receives the bank transfer. Relevant information about the training will be shared with participants in due course.

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, it is assumed that you accept these booking conditions.

***If You wish to pay by Credit Card, please follow this link : CREDIT CARD PAYMENT

_{***Please note that a 3% bank fee is applied as per financial regulations law.}

 Download registration form

Location: EXCiPACT Office, Rue Marie de Bourgogne 52, 1000 Brussels, Belgium

 

EXCiPACT website