ComplianceOnline

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

Instructor: Joy McElroy
Product ID: 704549
  • Duration: 4 hrs

recorded version

$549.00
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

Training CD

$599.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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:

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. 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 and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, auditing, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Ms. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, Good Documentation Practices, and GMP and GLP training.

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