Regulatory Inspections and Quality Audits

Why Should You Attend:

Regulatory Inspections and Quality Audits are something every Pharmaceutical and Biotech company should be familiar with. These can be inspections conducted by Health Authorities, such as the US Food and Drug Administration, or they can be audits the company does internally to either prepare for a Health Authority inspection, or just to ensure proper operations at their manufacturing sites. This course will cover the basics for both of these types of inspections and audits, including giving companies basics to be prepared for both the inspection/audit and the outcomes.

• Gain a better understanding of Inspections by Health Authorities
• Better understand reasons for conducting internal voluntary audits
• Understand the importance of Health Authority Communications with regard to Inspections
• Understand the roles of Regulatory, Quality Assurance, CMC and Manufacturing play in Inspections and Audits
• Better understand the outcomes of Inspections and Audits and what companies next steps should be in dealing with them

Areas Covered in the Webinar:

• FDA Audits/Inspections
• Other Health Authority Audits
• Pre-Inspection/Audit Preparation
• Internal Roles during an Inspection/Audit
• Dealing with the aftermath of Health Authority Inspections
• The 483 Form
• Internal Audit results and how to handle them
• Reporting requirements for internal audits

Who Will Benefit:

• Regulatory Affairs, Quality Assurance, CMC, Manufacturing

From

• Pharmaceutical Industry

Frequently Asked Questions:

• Our company have routine audits since the product is registered with FDA and data integrity is very important now. As we perform our departmental internal audits, what should we be looking for during our audits to help identify issues.

Free Materials:

• Rule documents or guidance
• Slide Show
• Checklist

Martin Lessem
Principal Consultant, Lessem Regulatory Consulting LLC

Martin A. Lessem, J.D. is a professional with 17 years of experience in Pharmaceuticals. In the past 12 years he has been heavily involved with Regulatory Risk Management and worked on many of the larger industry programs. He has worked at large companies, small companies, innovator companies, and generic companies and has worked in risk management in all those settings. Currently, he is a consultant to Pharmaceutical companies on Regulatory Strategy and Risk Management.

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