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 ofFDA 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.
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| GMP Training |
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.
For more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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