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.
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.
