EFFCI Certification support, EFFCI Consultancy, EXCIPACT Certification

EFFCI – Coverage in 2 Days

1. Introduction to EFFCI, the European Federation for Cosmetic Ingredients, the organization and functioning
2. Regulatory context for cosmetic ingredients in the EU and other parts of the world. International cosmetic legal and regulatory data base.
3. European cosmetic directive and EFFCI – Position of European Medicines Agency related to cosmetic ingredients
4. What are position papers published by EFFCI from time to time, their applicability, importance with examples
5. Importance of GMP’s in cosmetic ingredients and possible impact on consumer health
6. Risk analysis related to use of cosmetic ingredients in cosmetic products
7. Differences between ISO 22716 and EFFCI
8. Understanding the EFFCI standard in detail with interpretations
9. Process of certification to EFFCI.
10. What to expect during a Cosmetic GMP audit for ingredients? How to address the expectations of auditors?
11. Case studies to test the understanding of participants – How cosmetic GMP’s and applied in manufacturing context?
12. Customer specific requirements shall be included after understanding the context of training and objectives.

IPEC – EXCIPACT – Coverage in 3 Days

1. Introduction to IPAC-EXCIPACT, the standard for pharmaceutical excipients, the organization and functioning, its mission, vision and values.
2. Benefits of EXCIPACT scheme
3. Regulatory context for Pharma excipients various regions across the world. International legal and regulatory data base.
4. WHO-GMP requirements for pharmaceutical excipients
5. Importance of GMP’s in Pharmaceutical excipient industry and possible impact on consumer health
6. Risk analysis related to use of pharmaceutical excipients
7. The ISO 9001:2008 standard, basis of Excipact standard – How to adopt QMS in a excipient industry?
8. GMP and GDP standards suitable for 3rd party auditing
9. Definition of auditor competency for the delivery of the scheme
10. Certification scheme rules for 3rd party audit organizations
11. Publication, communication and on-going maintenance of the schemes, standards and guides developed.
12. Understanding the EXCIPACT standard in detail with interpretations
13. Process of certification to EXCIPACT.
14. What to expect during a GMP audit for Excipients? How to address the expectations of auditors?
15. Case studies to test the understanding of participants – How GMP’s are applied in manufacturing context?
16. Customer specific requirements shall be included after understanding the context of training and objectives.