This course will describe the basis for the performance and tools and techniques for performing internal audits in support of the development and manufacture of a pharmaceutical drug product.
The presentation will describe the role internal audits play in assessing a company’s compliance to GLP and cGMP regulations and in the development of a Quality System. The role of internal audits as part of CAPA related to internal (incidents, deviations) or external (regulatory inspectional observations) will be discussed. The role of senior management will be described in assuring compliance and follow-up to internal audit observations and corrective actions.
Tools, formats and strategies used for internal audits will be presented and discussed. Who comprises an internal audit team and why. Formats for conducting an internal audit, providing feedback, writing reports and assuring compliance to observations will be presented. How to approach the creation of a risk based gap analysis grid for use during internal audits and what you should and should not show a regulatory authority inspector during a regulatory inspection.
Why should you Attend: A successful robust internal auditing program allows you to understand your processes and assure a high level of compliance and discover the GAPs needing attention BEFORE the FDA!
An understanding of the why and how of internal auditing, and the practical tools, formats and approaches to use for internal audits. Among these will be techniques to use in difficult situations and the many different types of internal audits.
Areas Covered in the Session: