The Challenges of an Effective Change Control Program 2017

What topics are covered by the course?

Day 1 Schedule

Lecture 1:
Review the current regulatory requirements for change control. Discuss when change control needs to be implemented and the main items it should cover.

Lecture 2:
What are the major sections that need to be included in a change control procedure?

Lecture 3:
What are the typical industry challenges associated with change control? Review the benefits that a well-controlled change control process can provide.

Lecture 4:
What are the most common deficiencies cited by auditors when reviewing change control programs? Review the current regulatory requirements for change control.

Day 2 Schedule

Lecture 1:
Discuss when change control needs to be implemented and the main items it should cover.

Lecture 2:
What are the major sections that need to be included in a change control procedure?

Lecture 3:
Review the current FDA Guidance for the investigation of Out of specification results (OOS)

Lecture 4:
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.

Who should attend?

Quality Assurance
Quality Control
Manufacturing
Production
Regulatory
Laboratory Personnel
Management
Equipment Vendors

What will I be able to do on completion?

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.

How will I be assessed?

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?
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 current FDA Guidance for the investigation of Out of specification results (OOS)
Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc.

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901094SEMINAR?coursesplus-August-2017-SEO

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Guide Price: 1295


Outwood
Lancaster
Wakefield
Delivery: Classroom
Category: Health & Medical »
Duration: 2 days
Qualification: N/A

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