Impact Assessment for Change Control

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 Industries

Alan M Golden
Principal, Design Quality Consultants

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

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