- Identify the purpose of the API Q1 Technical Application for Lead Auditor.
- Discuss the business drivers for developing API Spec Q1.
- Describe both the Process-Based QMS and the Process and Risk-Based QMS auditing processes.
- Evaluate an API Q1 Stage I audit.
- Identify the requirements of an API Q1 Stage II audit.
- Conduct an API Stage II audit.
- Evaluate findings in an API Q1 Stage II audit.
- Complete an API audit report.
- Evaluate a QMS against the API Specification Q1.
- Conduct a closing meeting.
Who the course is for
This course is intended for personnel who participate on internal or external audits and who require additional knowledge and application for the API Q1 specification. It is intended for all personnel participate or support audits, including internal, supplier or API witness audits. Those involved in product, process or failure audits would also benefit from this program
This course utilizes the latest training methodologies and uses a combination of lecture, examination, and group auditing to ensure each participant is able to analyze properly, audit, documents, and report findings, concerns, and observations. This course covers all the technical requirements outlined in the specification. This course is the first in the industry that consists of conducting a full API Q1 audit against a fully documented QMS and records management system. Throughout the audit, participants undergo observations and receive competency assessments by Accredited Providers and Subject Matter Experts.