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.


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