Regulatory Inspections - How to prepare for a visit from an FDA Auditor

Instructor: Joy McElroy
Product ID: 705725
Training Level: Basic
  • Duration: 60 Min
This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

recorded version

$169.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2018

Training CD / USB Drive

$199.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

Why Should You Attend:

This presentation will cover how to best prepare for these inspections to ensure the process is as quick and seamless as possible. We will cover what they are required to ask for, what they will likely ask for, and how to ensure you provide information requested in a timely manner. We will also go over some tips and tricks that will also help in ensuring a smooth audit as well as how to respond to the FDA once the audit is complete. At the end of the presentation, I will answer any questions or concerns you may have regarding the FDA auditing process.

Areas Covered in the Webinar:

  • The purpose and scope of FDA audits
  • FDA forms 482 and 483
  • What exactly a QSIT audit entails and how to pass it
  • How to Develop an audit preparedness plan that you can use to execute the audit
  • Understand what the FDA will look for at the conclusion of your audit
  • Do's and Don'ts on how to address FDA representatives
  • Do's and Don'ts for your audit team
  • Tips and tricks to ensure smooth audit experience

Who Will Benefit:

  • Regulatory Professionals
  • Quality Assurance Professional
  • Executive Management
  • Individuals involved with FDA compliance
Instructor Profile:
Joy McElroy

Joy McElroy
Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 she moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, she moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 14 years of experience as a consultant, and 25 years total experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Analytical and Manufacturing Equipment Qualification, and Technical writing. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. She develops and delivers webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more. Joy also writes articles on these topics for various on-line magazines.

In 2013 she started my 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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