Regulatory Audit Preparedness

🎤  Alan M. Golden‎         |  📅  Recording Available   |  🕒  60 Minutes

Areas Covered In The Session: Preparing for a third-party audit or inspection Assembly of an audit team Prestaging of documents and records Preparing “back room” Conducting the audit Required staff Opening meeting Tours Notes and communication Responding to audit findings Response team How fast Next steps

Regulatory Audit training provides participants with valuable insights into effective preparation, execution, and response strategies. This comprehensive session covers the essential aspects of conducting successful audits and addresses the unique challenges posed by virtual audits in light of post-pandemic.

Regulatory Audit is an integral part of the medical device and pharmaceutical industry, where audit outcomes can significantly impact product approval and manufacturing operations. To ensure a favorable outcome, understanding the audit process and being equipped with the right resources, staff, and facilities are paramount.

The key to a successful regulatory audit lies in meticulous preparation and conducting the audit with utmost care. By focusing on strategic planning, appropriate staffing, and advanced preparations, you can greatly influence the outcome of the audit. This webinar delves into the crucial aspects of strategy, staffing, and proactive measures necessary to host a regulatory audit that yields positive results.

WHO SHOULD ATTEND: 

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Scientists
• Everyone that supports during an audit