Implementing Quality Control Tools in Quality Systems Operations (Pharmaceuticals Trai)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: May 26, 2011 End Date/Time: May 26, 2011
Report as Spam


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.

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.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.


Online Event
2600 E. Bayshore Road
Palo Alto
United States