subject: Implementing Quality Control Tools in Quality Systems Operations [print this page] Implementing Quality Control Tools in Quality Systems Operations
There are a number of Quality Control Tools which have been used in a multitude of global industries. The incorporation of Quality Control Tools in support of the Pharmaceutical Quality System offers manufacturers an effective way to evaluate their operations and achieve a state of control. Failures in achieving the latter frequently result in issuance of observations by regulatory authorities and may lead to additional regulatory actions.
The FDA employs a systems-based approach to inspection, including evaluations of the quality system and the five manufacturing systems, to ensure that the drug, biologics and medical device manufacturers are in a "state of control" and in compliance with regulatory requirements.
The US FDA published a guideline for industry entitled, "Quality Systems Approach to Pharmaceutical cGMP Regulations". The guideline was published for the purpose of aiding "manufacturers, implementing modern quality systems and risk management approaches" to meet cGMP regulatory requirements. Within the guideline, FDA described a comprehensive quality systems model incorporating the following elements: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities. The last element, "Evaluation Activities" focuses upon the topics of data analysis and trending, internal audits, risk assessment, corrective action, preventive action and process improvement.
This webinar will discuss multiple Quality Control Tools (e.g., Graphs, Pareto Chart, Ishikawa/Fishbone Diagram, Control Chart, 5 Why 2 H, Reverse Fishbone) including their purpose, advantages and disadvantages. The application of Quality Control Tools in the performance of data analysis and trending (i.e., stability data, environmental monitoring, rejects, training metrics, etc.) will be described. We will also discuss recent regulatory authority observations associated with the lack of cGMP compliance related to Quality Systems Operations.
Areas Covered in the Seminar:
Understanding the purpose of Quality Control Tools.
Advantages and disadvantages of using Quality Control Tools.
Discuss and provide examples of proactive Quality System "Evaluation Activities".
How to incorporate Quality Control Tools for a more effective Quality System.
Key cGMP Issues regarding lack of proactive "Evaluation Activities" as cited in Regulatory Authority Inspection observations.
Who Will Benefit:
This webinar will provide information to regulated industry including pharmaceutical, biotechnology & medical devices, responsible for the manufacture of cGMP products. Those functional roles that would derive the most benefit from this webinar include:
QA Managers/Directors
QC Managers/Directors
Quality Systems Personnel
Operations or Manufacturing Managers/Directors
Instructor Profile:
Felicia Ford-Rice, is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International, specializing in Strategic Compliance. Felicia has over twenty years experience working in Research and Development, Regulatory Affairs and Quality Assurance roles for Academia, the US Government, Vaccine and Pharmaceutical manufacturers. In previous roles she has led the creation of the following quality system elements: deviation/CAPA, investigation, effectiveness checks, management review processes, product disposition/ release, aseptic processing support, change control, product complaints, product recalls, quality agreements, EM trending, APRs, controlled documentation management, internal/external audits, supplier qualification, MRB, CRO/CMO oversight, regulatory authority inspection readiness, anti-counterfeiting communications.
