This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from 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 the 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:-

• 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