FDA Inspections: What Regulations Expect


Joy L. McElroy is Keynote speaker at ComplianceKey. Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering. Now with 14 years experience as a consultant, and over 20 years total experience in the pharmaceutical ........

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 this webinar?

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 indepth understanding of how to prepare for unannounced FDA audits and inspections.

Areas Covered in the Session:

  • The inspection Process
  • Legal Issues
  • Inspection Checklists
  • Part 11 Signatures
  • Archiving
  • Audit Trails
  • Mock Audits
  • Documentation
  • Report Writing
  • Responding to FDA 483's

Who can 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


Webinar Id: LSHCJM0001

Training Options:

Duration: 90 mins

  30-Mar-2017

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

Refund Policy
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