Change Control is among the areas for which the highest numbers of FDA 483’s get issued. Documentation and evaluation of Change Control are of critical importance to an effective Quality System program. Along with Out of Specification, Change Control has been a regular in the list of the 10 most cited GMP regulations for the past five years. If the nature and number of these citations are any indication, there is no reason to believe that this is going to change.
What happens when the FDA issues 483’s or take other types of penal actions against companies? There could typically be recalls, penalties and even resignations of personnel who hold high positions in the company. Yet, it is the company itself that is to blame for inviting citations from the FDA. If they have an understanding of how to handle Change Control and OOS properly and know how to document them, they can hold their head high and confidently go about their business.
Getting Change Control documentation right
Documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents are imperative to an effective quality system program, along with several regulatory requirements.
Controlling this process requires one to have a defined Change Control procedure that outlines responsibilities and documentation requirements, along with a form in which to record required information.
The success of a Change Control program and its ability to assure regulatory auditors that the laboratory’s equipment, utilities and systems remain in a state of control are determined by the effectiveness of these items.
A full and in-depth understanding of Change Control
All the aspects of Change Control, its documentation and the ways of handling OOS will be the teaching a seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.
Kenneth Christie, who is the chief operating officer for VTS Consultants, Inc. and has over three decades of experience in sterile manufacturing and regulatory GMP consulting in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries, will be the Director of this seminar.
In order to gain complete knowledge of all the aspects of Change Control and OOS, please register for this seminar by visiting Change Control is at the core of GMP Compliance. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Focus on the major aspect of Change Control and documenting it, and handling OOS
At this seminar, Kenneth will concentrate on three major points:
o The regulatory requirements for Change Control, along with what this change applies to
o The ways of developing a Change Control SOP that will define what is required, along with the responsibilities, and how to quickly provide summaries of changes to investigators
o Some of the common deficiencies cited by regulatory auditors.
Leading to insights needed to ask the right questions
Kenneth will also offer insights into the multiple benefits that a well maintained Change Control program brings to a company. He will also explain when Change Control is not required to be reviewed. The point of touching upon all these areas is that the participants will be equipped with the insight needed for asking questions on issues relating to their own Change Control procedure.
Just as things change over time, not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria, and are subject to change over time. When this happens, companies must first determine the cause, take the required corrective actions and then implement actions to prevent their recurrence.
The effectiveness of these actions lies in how far it is able to determine the root cause. If this is not done, no action can prevent their recurrence. Kenneth will teach how to conduct such investigations and what to expect from these investigations. He will focus on the FDA Guidance document in doing this. Actual case studies will be explained to strengthen the understanding of the various topics that are covered over these two days.
Professionals who work in any of the areas of Quality System and those whose work is related to Change Control in one or another way will benefit from this session. These include Quality Assurance, Quality Control, manufacturing, production, regulatory, laboratory personnel, management and equipment vendors.