This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs.
Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what to include in an audit, what to examine, where to look, to whom to speak, and what areas are the best indicators of problems.
Being able to find hidden signs of weakness or deviations that are not obvious are key to a good audit. Developing that talent and utilizing it are vital to the success of an audit and the auditor.
Being able to discover "the smoking gun" is a key talent of a great auditor. It is always easy to criticize after a problem causes a serious issue . . . it is difficult to see the problem coming and alerting people to its risk and potential. We will cover some of the opportunities you can seize to make your audits more productive and valuable.
Why should you attend: Auditing is a learned and developed skill that plays an important role in determining GMP compliance. This program will provide the participant with insight into what one needs to do to perform an effective audit of API suppliers. What should be performed during the preparation and performance of such audits and what documents to utilize. Also examined are the processes used to communicate and follow-up after an audit is completed.
Areas Covered in the Session:
* What does an audit need to accomplish?
* Preparing for an API Audit
* Initial survey questionnaires
* Examine initial or past history with the firm
* Identify signs
* Addressing signs discovered
* Looking at facilities
* Looking at Staff
* Looking at change controls and notification systems
* What do purchasers of API need to do?
Who Will Benefit:
* Quality Unit Supervisors/Managers/Directors
* Support Functions to Quality or Manufacturing
* Manufacturing Supervisors/Managers/Directors
* Regulatory Affairs personnel responsible for GMP Compliance and filings
* Support personnel responsible for GMP Related activities such as Calibration and Testing Functions
* Validation personnel
* R&D Professional, Supervision and Management
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