Overview
Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities.
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.
The FDA consistently has focused on complaints as part of post market surveillance. Numerous citations are related to deficiencies and lack of implementation or effective implementation of complaint handling activities, documentation, and the disconnect between complaints with CAPA/change control/adverse event reporting/recalls. Regulated companies don't always establish and implement a unified approach to these regulated systems.
Webinar Takeaway
This 90-minute accredited course is intended to help you better understand and get familiar with the requirements for complaint files and key requirements of:
- Complaint procedures
- Investigations
- What to document when it is determined that an investigation is not needed
- What actions are required if a complaint represents a reportable event
- Record retention
In addition, the course will incorporate the complaint handling life-cycle process and an example of activities involved in this life cycle. Furthermore, this webinar will discuss complaint handling implementation challenges, in addition to pitfall challenges. At the end of this course, there will be a conclusion section, where points to take into account with the integration of CAPA/change control/adverse event reporting/recalls/complaint files in the complaint handling life-cycle, will be detailed.
Who will Benefit
This course will be valuable to all individuals working within or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of commercial drug product released to the market and would be beneficial to professionals in:
- Quality Control
- Quality Assurance
- Technical Operations
- Contract Manufacturers
- Manufacturing and Filling Operations
- Research & Development
Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such inspections and reports would likewise find this course very worthwhile.
Faculty Danielle DeLucy
Principal/Owner, ASA Training & Quality Consulting, LLC
Gouldsboro, Pennsylvania
Danielle DeLucy, MS, is 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 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.
