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:
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.
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.
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.
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?
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. Discuss actual case studies to highlight topics covered. Question and answer period from the attendees.
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amhesrt, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE's Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.