DESCRIPTION One of the fundamental concepts of current Good Manufacturing Practices (cGMP) is that companies that manufacture and/or test medicines should be in a constant State of Control; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last. This State of Control is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990 the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated

Date : 11th December 2017 to 12th December 2017

Place : United Arab Emirates, Dubai

Website :https://www.eventbrite.com/e/pharmaceutical-qty-mgt-system-gmp-requirements-ich-guidance-qbd-usfdaema-regulations-com-a-tickets-38837742734?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last. This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated

DESCRIPTION One of the fundamental concepts of current Good Manufacturing Practices (cGMP) is that companies that manufacture and/or test medicines should be in a constant State of Control; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last. This State of Control is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990 the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated will be held in Dubai,United Arab Emirates on date 2017-12-12

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Deadline for abstracts/proposals : 10th December 2017

Keynote Speakers : Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their t

Conference Highlights :Learning Objectives: Upon completing this course participants should: -Understand the history and expectations for global regulators for Quality Management and a State of Control -Understand the vocabulary Quality Management including expectations for a “Quality Culture” -Understand aspects related to Quality Management -Understand the role and importance of Documentation -Understand the interaction and integration required for successful GMP operations -How to prepare and presen

Venue :Dubai - United Arab Emirates

Check the event website for more details.