Change Impact Assessments and Change Plans

This webinar will discuss strategies and processes around doing change impact assessments during change control to ensure appropriate impact is assessed and mitigated.

Webinar Outline:

1. Impact assessment as a part of change control
   1. The ability to assess the impact of a change is integral to the process of change control
   2. Must be an integral part of your change control procedure
   3. Not an option
2. Why do an impact assessment as part of change control?
   1. Regulatory guidance talks to ensuring all changes are reviewed, verified and/or validated as appropriate
   2. Determination of “appropriate” is a little vague
   3. Regulatory guidance does not provide much guidance on how to do an impact assessment
   4. The process and procedure must be part of internal SOPs
3. Quick review of the elements of a change description
   1. The change
   2. The reason
   3. The justification
      1. The justification comes from the impact assessment
      2. You can’t justify the change without assessing the impact of the change first
4. Low impact changes
   1. Not all changes require a comprehensive impact assessment
   2. There should be a predefined list of changes or change types that do not require a full impact assessment to justify
   3. This list of changes or change types should be part of an SOP and fairly short and well defined
5. Impact assessment team
   1. If it is determined that a full impact assessment is needed a team to do the assessment should be put together
   2. Can be permanent group or put together as needed
   3. Need someone to drive the change
      1. Acts as the project manager for the change
   4. Other functional areas depending on the nature of the change
6. Creating a change control roadmap
   1. The use of forms and decision trees is essential to success
   2. Team needs to have guidance and a place to record impact decisions
   3. Examples of decision tree and change impact assessment form
   4. Understanding of risk management impact and regulatory impact is critical
7. Conclusions and questions

Speaker:

Alan Golden, MS, Principal, Design Quality Consultants, LLC

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.

Why you should attend the session:

Change control is integral to Pharma and Med Device industries to ensure all changes are completely assessed and documented. Proper and complete impact assessments are critical to ensure changes are appropriate and don’t negatively impact other products or processes. This process can be cumbersome if a good strategy and procedures are not implemented.

Who Will Benefit from this Webinar:

This webinar is appropriate for anyone in the Pharmaceutical, Medical Device, or Combination Product Industry.

This webinar is for professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:

• Quality Systems
• Quality Assurance
• Quality Control
• Change Control
• Engineering/R&D
• Regulatory Affairs
• Validation
• Auditors
• GMP trainers
• Consultants

Registration Information:

Register Today!

Single Registration
Single Attendee: $208.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.

Group Registration
Group of 5 or less per location: $448.00 + HST CAD per session
Group of 6 to 10 attendees per location: $788.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1288.00 + HST CAD per session
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.