This laboratory documentation training Webinar will discuss the GMP requirements on laboratory records and how to streamline documentation system.
Why Should You Attend:Documentation system is critical in pharmaceutical industry as it must accurately record laboratory activities. Most of observations or warning letters are resulted from inadequate documentation. Over-documentation would lead to confusion and under-documentation would make it difficult to explain the activities. This presentation will discuss cGMP requirements on raw data and laboratory records. It will introduce the key factors to enhance the integrity of the data and understand the structure of SOPs.
Learning Objectives:Upon completion of this session, attendees will understand the role of the analytical program to support the drug development process. This would help scientists to learn of activities in this area whether they hold an active or supporting role. The course will also discuss observations and infractions and critical cGMP requirements for the laboratories.
Areas Covered in the Seminar: - Review cGMP requirements on laboratory records.
- Define raw data.
- Key factors of an effective documentation system.
- Anatomy of an SOP.
- Consequences of poor data records.
- Discuss warning letters effecting the analytical data.
Who Will Benefit:
- Pharmaceutical scientists
- Manufacturers or raw material and ingredients
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
