This webinar was intended to provide an overview for use and value of the recently published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.
Lack of a unified industry approach to certification body qualification has resulted in pharmaceutical companies independently developing their own procedure. The IPEC Guide was developed and designed to facilitate a consistent approach for excipient users to qualify an excipient-certification scheme owner (SO) and certification body (CB).
The webinar will covered the history and purpose for developing the IPEC guide, raise awareness of the need for a qualification process, and share examples for how the guide can be used by industry.
During this webinar attendees will be provided with background and introduction to the IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients as well as the value for use of the guide from the perspective of a scheme owner, certification body, excipient supplier and excipient user.
Attendees will be provided with examples for:
> how to qualify a 3rd party certifying body
> how to know when an auditor is qualified to the standard
> how to determine what certifying standard(s) might be right for them
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality assurance
> Regulatory authorities