The Challenges of an Effective Change Control Program and How to Address OOS Results training seminars presented by ComplianceOnline register now on FindaSeminar.com

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The Challenges of an Effective Change Control Program and How to Address OOS Results  

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Seminar Summary:

In addition, the seminar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. (see full course description)

 

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Training Course Syllabus:


The Challenges of an Effective Change Control Program and How to Address OOS Results

Course Description

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control.

This seminar will concentrate on three major points:

The regulatory requirements for change control and what it applies to.

How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators.

What are some of the common deficiencies cited by regulatory auditors?

In addition, the seminar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. Attendees will be able to ask questions on issues relating to their own change control procedure.

Learning Objectives:

This seminar will define the regulatory expectations, the typical components of a change control procedure and typical form, typical deficiencies cited by regulatory auditors, along with the current proposed FDA guidance on addressing out of specification results. Attendees will have plenty of opportunity to ask questions and actual case studies will be used to highlight various topics given.

  • Review the current regulatory requirements for change control

  • Discuss when change control needs to be implemented and the main items it should cover

  • What are the major sections that need to be included in a change control procedure?

  • What are the typical industry challenges associated with change control procedures?

  • Review the benefits that a well-controlled change control process can provide

  • What are the most common deficiencies cited by regulatory auditors when auditing change control programs?

  • Discuss when change control needs to be implemented and the main items it should cover

  • What are the major sections that need to be included in a change control procedure?

  • What are the typical industry challenges associated with change control procedures?

  • Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc.
  • Topic Background:

    It is said that the two things no one can avoid in life are death and taxes, but in industry, these items are change control and out of specification results that will eventually happen. How we document them and their evaluation are critical to an effective quality system program. In review of the top 10 most cited GMP deficiencies, these two topics have routinely made the top 10 list for the last five years and understanding how best to address them will help companies avoid getting cited for the same issues.

    DAY 01(8:30 AM - 4:30 PM)

    Session 1: Review the current regulatory requirements for change control. Discuss when change control needs to be implemented and the main items it should cover.
    Session 2: What are the major sections that need to be included in a change control procedure?
    Session 3: What are the typical industry challenges associated with change control? Review the benefits that a well-controlled change control process can provide.
    Session 4: What are the most common deficiencies cited by auditors when reviewing change control programs? Review the current regulatory requirements for change control.

    DAY 02(8:30 AM - 4:30 PM)

    Session 5: Discuss when change control needs to be implemented and the main items it should cover.
    Session 6: What are the major sections that need to be included in a change control procedure?
    Session 7: Review the current FDA Guidance for the investigation of Out of specification results (OOS).
    Session 8: Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc. Discuss actual case studies to highlight topics covered. Question and answer period from the attendees

    Seminar Summary:

    In addition, the seminar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. (see full course description)

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