4-Hr Virtual Training: How to Respond to an FDA Investigation

Instructor: Joy McElroy
Product ID: 704549
  • 16
  • January 2020
    Thursday
  • 08:00 AM PST | 11:00 AM EST
    Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Live Online Training
January 16, Thursday 08:00 AM PST | 11:00 AM EST | Duration: 4 hrs

$399.00
One Dial-in One Attendee
$799.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$449.00
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 48 hrs after completion of Live training

Training CD / USB Drive

$549.00
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 after completion of Live training

Combo Offers

Live + Recorded Version

$549.00

Live + Training CD/USB

$599.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

This webinar will illustrate how to respond to an FDA investigation. It could be a 483 observation, a warning letter, or a consent decree, all of which will impact how you carry on your business while under investigation.

The course will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Learning Objectives:

  • What should a company do if the FDA shows up unannounced
  • How should a company respond to 483 observations or a warning letter
  • The effect an FDA investigation can have on a company
  • The basic concepts that should be employed by everyone regulated by the FDA
  • How a company can prepare for situations like this
  • Lesson learned
  • How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

Areas Covered in the Webinar:

  • Unannounced FDA visits
  • Responding to a 483 or a warning letter
  • Effect of an FDA investigation
  • Basic concepts that should be employed by everyone regulated by the FDA
  • Preparing for FDA audits
  • Lessons learned
  • Balancing preparing for the FDA investigation or enforcement action and still running a profitable business

Who Will Benefit:

  • Quality Assurance Staff
  • Quality Control Staff
  • Engineers
  • IT Staff
  • Manufacturing Supervisors and Managers
  • Documentation Staff
  • Directors, Managers, Supervisors
Instructor Profile:
Joy McElroy

Joy McElroy
Principle Consultant, Maynard Consulting Company

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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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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