FDA Inspections: What Regulations Expect

OVERVIEW

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. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required documentation, formats, archiving, as well as how to respond to inspection and audit results.

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. One will also gain a more in depth understanding of how to prepare for unannounced FDA audits and inspections.

AREAS COVERED

• The inspection Process
• Legal Issues
• Inspection Checklists
• Part 11 Signatures
• Archiving
• Audit Trails
• Mock Audits
• Documentation
• 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
• Consultants
• Senior quality managers
• Validation engineers
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners
• Quality engineers
• Quality auditors

LEARNING OBJECTIVES

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.

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Others Details

Learn how to prepare for FDA inspection, including what are the approaches, procedures and expectations of FDA inspectors.