The Challenges of an Effective Change Control Program 2017
Course "The Challenges of an Effective Change Control Program and How to Address OOS Results" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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 webinar 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.
As sure as we know things will change over time, the same we know that not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria. Once this happens, companies must first determine cause, take the required corrective actions and then implement actions to prevent their re-occurrence. The effectiveness of these actions is being able to determine the root-cause otherwise actions taken will not prevent them from happening again. This second part of the seminar will focus on the FDA Guidance document as to how to conduct such investigations and what is expected. Actual case studies will be used to highlight the various topics covered.
Why you should attend:
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.
Areas Covered in the Session:
• 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.
Who Will Benefit:
• Quality Assurance
• Quality Control
• Manufacturing
• Production
• Regulatory
• Laboratory Personnel
• Management
• Equipment Vendors
Agenda:
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
Overview:
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 webinar 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.
As sure as we know things will change over time, the same we know that not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria. Once this happens, companies must first determine cause, take the required corrective actions and then implement actions to prevent their re-occurrence. The effectiveness of these actions is being able to determine the root-cause otherwise actions taken will not prevent them from happening again. This second part of the seminar will focus on the FDA Guidance document as to how to conduct such investigations and what is expected. Actual case studies will be used to highlight the various topics covered.
Why you should attend:
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.
Areas Covered in the Session:
• 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.
Who Will Benefit:
• Quality Assurance
• Quality Control
• Manufacturing
• Production
• Regulatory
• Laboratory Personnel
• Management
• Equipment Vendors
Agenda:
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
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