Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues

This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA's Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA.

Learning Objectives:

Understanding the various implications of not adhering to the rules and regulations of the specific requirements guiding each product types and observed mistakes made by some manufacturers of products that led to the closure of several manufacturing site through an FDA injunction and further bankruptcy of a cGMP product manufacturer will be discussed. 

Who will Benefit:

The Seminar will benefit people within the pharmaceutical, biotechnology or medical device industries that currently have a stability testing program but are not savvy about maximizing the use of their data for extending their product’s expiration dating. The employees who will benefit most include:

Quality Control Analyst and Management

Senior Management

Manufacturing Associates and Management

Shipping and Distribution Personnel

Stability Testing Department Personnel and Management

Regulatory Affairs

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-form-483-warning-letters-seminar-training-80321SEM-prdsm?channel=sciencedz