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Impact Assessments and Risk Management for Change Control

Duration : 60 Minutes

Alan Golden,

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 pa Read more

Change control or change management is an integral part of todays regulated pharmaceutical and medical device industries (as well as others). The need to control and assess changes being made to previously approved documents ensures that any and all changes are implemented in a careful and thoughtful way. 

An all too common observation during a regulatory audit or during a product nonconformance investigation is that changes were made to the product through the product documentation that were actually harmful to the product performance or that proper studies were not undertaken to ensure the product continued to meet design goals. Another consequence of an inadequate change control strategy is when making changes to one product adversely impacts another product or multiple products. 

When assessing changes, it is important to take risk management into consideration before, during and after the change. Determining the risk level of the change can guide how or even if the change is implemented. 

Course Objectives:

• Understand the change control process.

• Understand the critically important impact assessment process and develop tools for effective impact assessments.

• Learn how to integrate risk management into the change control process.

Course Outline:

I. Impact assessment as a part of change control

a. The ability to assess the impact of a change is integral to the process of change control

b. Must be an integral part of your change control procedure

c. Not an option

II. Why do an impact assessment as part of change control?

a. Regulatory guidance talks to ensuring all changes are reviewed, verified and/or validated as appropriate

b. Determination of “appropriate” is a little vague. 

c. Regulatory guidance does not provide much guidance on how to do an impact assessment

d. The process and procedure must be part of internal SOPs

III. Quick review of the elements of a change description

a. The change

b. The reason

c. The justification

i. The justification comes from the impact assessment

ii. You can’t justify the change without assessing the impact of the change first

IV. Low impact changes

a. Not all changes require a comprehensive impact assessment

b. There should be a predefined list of changes or change types that do not require a full impact assessment to justify

c. This list of changes or change types should be part of an SOP and fairly short and well defined

V. Impact assessment team

a. If it is determined that a full impact assessment is needed a team to do the assessment should be put together

b. Can be permanent group or put together as needed

c. Need someone to drive the change

i. Acts as the project manager for the change

d. Other functional areas depending on the nature of the change

VI. Creating a change control roadmap

a. The use of forms and decision trees is essential to success

b. Team needs to have guidance and a place to record impact decisions

c. Examples of decision tree and change impact assessment form

d. Understanding of risk management impact

i. Simple tool for risk management during change control

e.  Understanding regulatory impact

VII. Conclusions and questions

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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