In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities.
WHY SHOULD YOU ATTEND
One should attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. One will gain a better understanding of the parameters, approaches, and concerns of FDA inspectors.
• The inspection Process
• Legal Issues
• Inspection Checklists
• Part 11 Signatures
• Audit Trails
• Mock Audits
• Report Writing
• Responding to FDA 483’s
WHO WILL BENEFIT
• Quality Assurance Managers and Supervisors
• Validation managers and Supervisors
• Engineering Managers and Supervisors
• Regulatory Affairs Managers and Supervisors
• Manufacturing and Operations managers and Supervisors
• Laboratory managers, supervisors and analysts
• IT managers and staff
Attending the webinar will give you a thorough understanding of the expectations and procedures of FDA inspectors. It will help you understand and devise strategies to be prepared for and manage inspections in manufacturing facilities.
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