Description:
Safety and efficacy of a drug product are established with clinical studies throughout drug development. Therefore, analytical procedures are required to be fully validated for their intended use of the approved conditions. When changes are made to an approval process, there are concerns of maintaining product quality as well as cost of process improvement. Pharmaceutical companies are required to establish a change control process to evaluate potential changes and minimize the impact of registration. Establishment of new specifications as a result of method changes will also be discussed.
This live and interactive webinar will focus on potential changes of analytical procedures, and how to develop a change control system that minimize impact of registration. Characterize these changes will also be discussed to ensure the analytical procedures continue to perform within validated state. Documentation system will also be discussed to complete the record of these changes and able to monitor the product as long as it is available on the market.
Learning Benefits:
- Understanding cGMP requirements of method validation.
- Review Q2 A&B for method validation activities.
- Discuss changes that may be necessary for analytical procedures.
- Discuss the key elements of change control system.
- Establish a change control so that these method changes can be verified.
- Documentation system necessary to verify that procedure continues to be valid within its intended use.
- Establish new specifications resulted from method changes.
Webinar outline:
- Understanding cGMP requirements for method validation,
- Change control: key element of the quality system,
- Review Q2 A&B for method validation activities,
- Discuss the key elements of change control system,
- Establish a change control so that these method changes can be verified,
- Documentation system necessary to verify that procedure continues to be valid within its intended use,
- Establish new specifications resulted from method changes,
- Live Questions & Discussion
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Validation
- Research & Development
- Auditor Professionals
- Regulatory Affairs Professionals
