Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

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

Instructor Profile:

Mitchell L. Ehrlich, has been involved in the management of Quality Assurance, Quality Control and Regulatory Affairs of pharmaceuticals, biopharmaceuticals and medical devices for almost forty years. Mr. Ehrlich has been responsible for regulatory inspection management, regulatory compliance policy and has managed the Quality Assurance operations of multiple manufacturing operations in the United States and in Europe. Mr. Ehrlich founded GxP Compliance Associates, LLC in 2013 to provide compliance consulting services for small to mid-size pharmaceutical and medical device manufacturing firms and start-ups. His consultancy also provides audit services for supplier audits; internal audits from an external viewpoint and GMP due-diligence audits of potential acquisition targets.

He is a Public Health Microbiologist and did his graduate level coursework at the University of Maryland and completed a Certificate Program in Management Leadership from the University of Pennsylvania’s Wharton School of Business.

Topic Background:

We live in a litigious society today. This is no more evident than in the pharmaceutical industry. If you watch television on any given day you will see the advertising for the lawyers looking to file suit against pharmaceutical companies. Pharmaceutical company employees also have been known to call the FDA or other regulatory agency when they feel that their concerns regarding the company’s compliance to GMPs or other regulations are being ignored. Through legal precedent, the FDA has gained the authority to visit and interview your employees outside of the work environment, thus outside of the influence of their supervisors and managers.

The internal audit program provides a means, when properly executed, to provide an independent and listening ear to those employees within the company that have concerns regarding the firms compliance to regulatory requirements, while the problem may still be resolved in-house. It can provide valuable information to Senior Management about the compliance status of the company, that when responded to in a timely and effective way can potentially result in savings of millions of dollars.

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