4-Hr Virtual Training: How to Respond to an FDA Investigation
Instructor:
Joy McElroy
Product ID: 704549
- Duration: 4 hrs
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
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.
More Training By Experts
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- Practicing Laboratory Safety in the Workplace
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- Best Practices for an Effective Cleaning Validation Program
- FDA Regulations for Environmental Monitoring (EM) Program
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
