This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
10/04/2018 10:00 AM10/04/2018 04:00 PMTraining Topic: FDA - Streamlining Your Internal Auditing ProcessInstructor: Betty Lane
Objectives of the Presentation
Understanding the value of internal audit to your company
Understanding internal vs. external audits
Streamlining your audit process
Follow-up and closure
Understanding what you need and do not need to show the FDA about your internal audits
Why Should you Attend
Does your current auditing program assure that you are meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance? Does it assure that you are meeting all European and Canadian requirements, if you sell products in those areas? If not or if you do not know, this webinar will explain how these are incorporated into your audit program without adding a lot of additional audits.
This webinar will cover how to create a value-added internal auditing system including how to plan a realistic annual internal audit schedule that covers all the requirements of your company's quality system.
Develop or streamline an internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
Manage an internal audit system
Difference between internal and external audits
How the internal auditing system can add value to your quality system and your company
What makes a good internal audit
Skill required for an internal auditor
What the FDA must see to verify that you are conducting your internal audits as required