Developing and Implementing an Effective Change control Procedure in the Pharmaceutical Laboratory.

Developing and Implementing an Effective Change control Procedure in the Pharmaceutical Laboratory

25 August 2011

Palo Alto, California, United States

 Website: http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=702021?channel=confalert

Contact name: Referral

 Description

 Why Should You Attend:

 This course is designed to provide participants with an understanding of regulatory requirements for Change Control as they relate to the Pharmaceutical Laboratory, and information which will be helpful in designing and implementing a procedure which addresses those requirements.

 Practical examples and a review of some recent FDA Warning Letters and 483's will be included.

 Learning Objectives:

 Upon completion of this course the learner should be able to:

 * Understand the regulatory basis for Change Control, with emphasis on how they relate to the Pharmaceutical Laboratory.

* Understand the key components in change control: Who, What, When, Why

* Identify the key elements which should be included in a Change Control SOP

* Identify benefits of effective Change Control and strategies to maximize efficiency

* Effectively prepare for an FDA inspection as it relates to Change Control

Areas Covered in the Seminar:

 * The regulatory basis for Change Control requirements.

* The Key Components in Change Control: Who, What, When, Why.

* The scope of Change Control in the Laboratory: SOPs, Specifications, Methods, Analytical Equipment, Computerized Systems.

* The key elements which should be included in a Change Control SOP.

* Implementing a Change Control Process, with examples.

* Benefits of effective Change Control, and strategies to maximize efficiency.

* Review of some FDA Warning Letters and 483's related to Change Control, with hints on preparing for an inspection.

Who Will Benefit:

 * Laboratory personnel

* Managers of analytical Laboratories

* Managers of Quality Control Laboratories

* Quality Assurance

* All personnel responsible for assuring that appropriate control of changes related to the laboratory are maintained

Instructor Profile:

                Gregory Martin, is the founder and President of Complectors Consulting LLC, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Greg is Vice Chair of the USP General Chapters Expert Committee, and has over 29 years experience in the pharmaceutical industry, including ten years as Director of Pharmaceutical Analytical Chemistry in Merck Research Laboratories. Greg's interests include impurities and residual solvents, dissolution, analytical instrument qualification and other topics related to laboratory GMP compliance.

               This 2 hour webinar will help you understand of regulatory requirements for Change Control as they relate to the Pharmaceutical Laboratory and show how to prepare for an FDA inspection as it relates to Change Control.

Organized by: ComplianceOnline

Deadline for abstracts/proposals: Not available.