Change Control is at the core of GMP Compliance

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.

Preventing 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.

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing Practices(GMP).

Not a uniform set of standards

It needs to be understood that GMPs are not a uniform or homogeneous set of rules for everyone to follow. These are general principles laid out for ensuring that there is a minimum level of quality requirements to be fulfilled.

Agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products recommend these guidelines. These guidelines can be accomplished in many ways, and it is up to the organization to find out the one that suits it best and implement that system.

In essence, Good Manufacturing Practices can mean the following:

  • GMPs are set practices that manufacturers need to put in place to ensure that their products meet specified quality standards.
  • GMP guidelines consist of the minimum requirements that food product, drug or pharmaceutical manufacturers have to meet to assure that their products are of the prescribed quality and cause no harm or risk to those who consume them or the public at large
  • Regulatory agencies in several countries oversee their respective countries’ and global Good Manufacturing Practices. Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) are usually analogous to GMP
  • In many countries, legislations require pharmaceutical and medical device manufacturers to comply with GMP procedures. Many require these organizations to create their own GMP guidelines that are line with their legislations.

Basic points in GMP guidelines

These are the current GMP compliance requirements for pharmaceuticals (some of these guidelines overlap with those for medical devices)

 

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