This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.
This webinar will provide insight into how to conduct an internal audit program that is effective. It will discuss:
What works and what doesn’t work in organizing an internal audit program?
FDA’s expectations in what the regulated firm must do with the information that it obtains from the internal audit program.
Who should be involved in the conduct of the internal audit?
Why Should You Attend:
Internal auditing of pharmaceutical manufacturing operations is a common part of most quality system plans today. There are many different ways to accomplish internal auditing, and some ways are better than others. When done properly, internal auditing does more than just create another list of Corrective and Preventive Actions (CAPA) to complete. It can be a means to help an employee decide that they do not need to talk to the FDA or another Agency regarding their concerns with the plants’ compliance status.This webinar will provide insight into how to conduct an internal audit program that is effective. It will discuss:
What works and what doesn’t work in organizing an internal audit program?
FDA’s expectations in what the regulated firm must do with the information that it obtains from the internal audit program.
Who should be involved in the conduct of the internal audit?
Areas Covered in the Webinar:
- Regulations regarding internal audit programs
- Reasons for performing internal audits
- Management responsibility and ICH Q10
- Ground rules for conducting internal audits
- Auditor objectivity
- Benefits of a well-designed internal audit program
- Whistleblower laws
- Reporting to Management
- Dealing with the employee with concerns
- Follow-up on action items
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in pharmaceutical/biopharmaceutical manufacturing plants in the U.S. or shipping product for sale in the U.S. The following titles will benefit:- Pharmaceutical Manufacturing Professionals
- QA/QC Personnel
- Internal Auditors
- Manufacturing Operations Management
- Risk Management
- Regulatory Compliance Associates and Managers
Course Provider
Mitchell Ehrlich,
