This webinar will discuss multiple Quality Control Tools used in manufacture of pharmaceutical and biotech products, their purpose, advantages and disadvantages. You will learn how to implement cGMP compliance related to Quality Systems Operations.
Why Should You Attend: 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.
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.
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117660 ) To Get 10% Discount.
