Implementing Quality Control Tools in Quality Systems Operations (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: May 26, 2011||End Date/Time: May 26, 2011|
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 â€œstate of controlâ€ and in compliance with regulatory requirements.
The US FDA published a guideline for industry entitled, â€œQuality Systems Approach to Pharmaceutical cGMP Regulationsâ€. The guideline was published for the purpose of aiding â€œmanufacturers, implementing modern quality systems and risk management approachesâ€ 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, â€œEvaluation Activitiesâ€ focuses upon the topics of data analysis and trending, internal audits, risk assessment, corrective action, preventive action and process improvement.
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.