Answering and Replying to an FDA 483
Danielle DeLucy, MS, is the owner of ASA Training and
Consulting, LLC which provides Pharmaceutical and Biologics based
companies with training and quality systems assistance in order to meet
Regulatory compliance. Prior to this role, Danielle has been in the
the industry for 15 years serving in numerous Quality Management Roles, such
as the Director of Product Quality, the oversight of Sterility
Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control
Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead much Regulatory Health
Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees, and those wishing to improve compliance to establish more robust quality systems so that the company can succeed.
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or break your organization and its standing with the regulators.
- GMP Compliance
- Regulatory requirements
- Do’s and don’ts
Course Level - Basic understanding of GMP compliance principles. Experience with 483 observation response
Who Should Attend
- Those new to the practice and those who would like an update
- Experienced as well as inexperienced
Why Should You Attend
If you are new to the topic or need to brush up on the expectations or how to react to 483s consider attending.