The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
This seminar is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. FDB3088
- Understand what a regulatory compliance audit is.
- Understand the background and basics of regulatory compliance auditing.
- Understand proper Auditor conduct.
- Difficult situations
- Learn the necessary skills for conducting audits.
- Understand how to prepare and plan for a regulatory compliance audit.
- Understand and know how to properly perform an audit.
- Opening meeting
- Touring the facility
- Close out meeting
- Understand the types of regulatory compliance audits
- Learn proper questioning techniques
- Understand proper audit observation classification
- Learn to write an audit report
- Understand conducting a follow up audit
- Learn how to become Lead Auditor certified
- ASQ Certification
- ISO Certification
- Medical Device Certification