Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.
Companies in the pharmaceutical and medical device space are required to implement formal change control for most design, production and procedure documents. When these documents change or are updated, the impact of the change must be assessed. In this webinar, you will learn why a complete impact assessment is critical and come away with tools to help categorize and work through the assessment. Topics such as the difference between high and low impact changes, verification and validation of changes and proper documentation will be discussed.
Why Should You Attend:
All companies in the pharmaceutical and medical device space are required to implement formal change control. Issues with change control are a major contributor to FDA observations during inspections. Incomplete or non-existent assessment of the impact of changes can lead to inadvertently breaking something else while trying to fix a problem or upgrade a system. It can lead to product which is no longer fit for market, or lead to production issues increasing CAPA and scrap costs. This training is designed to provide tools and processes to make the assessments of changes easier to manage and therefore more likely to be completed in a satisfactory and compliant manner.Companies in the pharmaceutical and medical device space are required to implement formal change control for most design, production and procedure documents. When these documents change or are updated, the impact of the change must be assessed. In this webinar, you will learn why a complete impact assessment is critical and come away with tools to help categorize and work through the assessment. Topics such as the difference between high and low impact changes, verification and validation of changes and proper documentation will be discussed.
Areas Covered in the Webinar:
- FDA regulations around change control
- ISO guidance around change control
- Categories of changes
- Change and the drivers of change
- Classification of changes
- Impact assessments - The justification behind the change
- Strategies for completing impact assessment
- Tools for impact assessments
Who Will Benefit:
- QA professionals
- Technical scientists
- Production staff
- Regulatory affairs professionals involved in change control
From
Medical Device and Pharmaceutical IndustriesCourse Provider
Alan M Golden,
