Change Control CONTENT Package

A one hour webinar recording, PDF PowerPoint presentation, audit checklist, FAQ and Answers document and a DVD Interview

➢ 1. Change Control Hot Topics: FDA/Global Regulatory Inspections (One Hour Webinar Recording)

➢ 2.Change Control Hot Topics: FDA/Global Regulatory Inspections (PDF PowerPoint Training Presentation)

Click here to view complimentary excerpt

➢ 3. Change Control Audit Checklist

Click here to view complimentary excerpt

➢ 4. Change Control FAQ and Answers Document

➢ 5. Managing an Effective Change Control Program: Critical Considerations (DVD Interview - click here to see video clip)

1. and 2. Change Control Hot Topics: FDA/Global Regulatory Inspections (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

 Click here to view complimentary excerpt

➢FDA requirements for a change control program - Drug products, Medical devices, Active Pharmaceutical Ingredients (APIs)

➢“Hot topics” from the FDA (including specific examples from Warning Letters, 483’s, and other sources from 2008 – present) regarding: Documentation of changes, Approval of changes, Rationale for changes, Validation of changes, Use of risk assessment to evaluate changes, Importance of assessing changes both looking forward and looking backward, FDA’s view of “like-for-like” changes, Inclusion of changes in annual product reviews, “Mandatory” changes, Management of computer system changes

➢International regulatory “hot topics” on change control, such as: Why do we need to assess the impact of productivity and capacity changes on quality operations?, When is like-for-like not really like-for-like?

➢Assessing your own change control program: Specific actions that can prevent similar issues in your operations – for each Warning Letter or 483 example noted, a specific action which might have prevented the citation will be discussed, Use of the Change Control Audit Checklist to identify and bridge potential compliance gaps

3. Change Control Audit Checklist

Click here to view complimentary excerpt

This five-page checklist contains 57 items related to effectively auditing change control program, including:

➢Basic elements of a change control program

➢Scope of change control program

➢Assessment of potential changes

➢Review, approval and documentation of changes

➢Verification of changes

4 .Change Control FAQ and Answers Document

➢This three (3) page documents provides answers to following questions related to:

➢The most common or most serious deficiency noted by FDA investigators related to change control.

➢Is it necessary that the Quality Unit review all maintenance work orders?

➢The FDA’s current view of “like for like” changes

➢Do PLCs need to be assessed through the change control program?

➢What about equipment using “recipes” that are programmed into the process?

➢Should we include changes in personnel (duties, work location, etc.) in the formal change control program, or is management of personnel a responsibility of the area supervisor?

➢What activities and documentation would the FDA expect regarding a move of an operator from one area to another?

➢The key emerging concern of FDA or international regulatory agencies regarding change control in pharmaceutical or medical device manufacturing operations

5. Managing an Effective Change Control Program: Critical Considerations (DVD Interview - click here to see video clip)

Boston Scientific is the largest manufacturer of medical devices in the world. They currently have 26 global manufacturing, distribution and technology centers. They deliver more than 13,000 products in over 45 countries. In this DVD, John Daley, VP Quality Assurance, Distribution and Supply Chain shares with viewers his thoughts on a number of issues related to managing an effective change control program.

➢Steps to Take When a Process is Out of Control

➢Impact Assessment That is Part of Change Control, Including Impact on Regulatory Filings

➢Electronic Systems That Track Changes

➢Approving Changes After the Filing Is Made

➢Informal Change Control Systems i.e., email Notifications

➢Defining and Managing a Scalable Change Control Process

➢Change Control as a Substitute for Validation

➢Evaluating Computer Validation Change Control Management Systems: One Set of Criteria To Avoid

➢Qualifying Personnel Related to Change Control

➢Handling Like-For-Like Changes

➢QA Approval for Changes

➢Routine Maintenance

➢Change Control Program Extending Back into Clinical Development

➢Evaluating the Impact of Change

➢And More

*DVD to be shipped separately.

Change Control CONTENT Package is only $99.00 -