Auditing and Qualifying API Suppliers

Venue: Washington

Location: Washington, Washington DC, United States

Event Date/Time: Aug 10, 2010 End Date/Time: Aug 11, 2010
Registration Date: Jul 28, 2010
Early Registration Date: Jun 30, 2010
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A Two-Day Comprehensive and Interactive Course with Workshops on:
Why audit API Manufacturers?
The roles of secondary manufacturers
Background to ICHQ7
How the regulations are enforced by the regulators and how they assess compliance to the regulations
How to implement the regulations into your company
FDA GMP expectations of API manufacturers
How to create a successful and efficient API supplier qualification program
How to identify and select a GMP compliant API supplier
Qualification & Approval of API Suppliers/Vendors – Quality Agreement/Contracts
Managing Changes in supplier/vendor
Handling Manufacturing Deviations
Auditing of an API site
Preparing for the audit – checklist and plan
Expectations from API manufacturers
Audits – a risk-based approach to determine the requirements and levels of the assessments
Communication and documentation with the suppliers
Identifying and documenting GMP non-compliance incidents in the API supplier
Reduced QC Testing of API from Qualified Suppliers
A Full day Interactive Workshop on Value added Auditing:

Auditing techniques required for a value added audit
Auditor’s credentials, in terms of handling auditees, from the new ISO 9000 guidelines
Examples of actual auditing situations and how to handle the presented situations
A mock audit of API supplier
Group discussions about common questions related to auditing