FDA Inspections: What Regulations Expect

    /Joy  /McElroyspeaker of Training Doyens
    Speaker: Joy McElroy


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    Duration: 90 Minutes
    Product Code: 50125
    Level: Intermediate

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

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.

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

SPEAKER

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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