FDA Case Scenarios – Best Practices for Managing Inspection Situations
Duration : 75 Minutes
Danielle DeLucy, Pharmaceuticals, Biotechnology
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, suc Read more
Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety and Inspection team situations. We will examine what went right and how the situation may have been handled differently.
Course Objectives:
Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations. Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled.
Course Outline:
• What to expect during an FDA inspection
• Real-life scenarios and how to properly respond
• Analysis of different Case Studies
• Managing difficult situations
• Tips for a successful audit
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Site Quality Operations Managers
• Quality Assurance Departments
• Plant Managers and Supervisors
• Manufacturing Departments
• Regulatory Affairs Departments
• Individuals whose job knowledge and/or expertise may be called upon during an audit
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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