New York Professional Events List


The Challenges of an Effective Change Control Program and How to Address OO


Date
Dec 14, 2017 - 08:30 AM - Dec 15, 04:30 PM
Organizer
New York Media Technologies LLC in association with METRICSTREAM INC.
Location
NewarkNewark, NJUnited States,

Newark,
NJ ,
US,
ZIP: United States
Phone:


 

Description

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 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.


Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

This seminar will define the regulatory expectations, the typical components of a change control procedure and typical form, typical deficiencies cited by regulatory auditors, along with the current proposed FDA guidance on addressing out of specification results. Attendees will have plenty of opportunity to ask questions and actual case studies will be used to highlight various topics given.

  • 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?
  • 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 typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc.
 

Who will Benefit:

This course is designed for people who are involved with the manufacture of drug products, medical devices and even contract manufacturers. The following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Suppliers and Vendors
  • Process owners
  • Quality engineers
  • Quality auditors
 

Topic Background:

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.



Agenda


Topic Background:

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.

 

DAY 01(8:30 AM - 4:30 PM)
 
  • Registration Process - (8:30 am till 9:00 am)
  • Session 1: Review the current regulatory requirements for change control. Discuss when change control needs to be implemented and the main items it should cover.
  • Session 2: What are the major sections that need to be included in a change control procedure?
  • Session 3: What are the typical industry challenges associated with change control? Review the benefits that a well-controlled change control process can provide.
  • Session 4: What are the most common deficiencies cited by auditors when reviewing change control programs? Review the current regulatory requirements for change control.


DAY 02(8:30 AM - 4:30 PM)
 
  • Session 5: Discuss when change control needs to be implemented and the main items it should cover.
  • Session 6: What are the major sections that need to be included in a change control procedure?
  • Session 7: Review the current FDA Guidance for the investigation of Out of specification results (OOS).
  • Session 8: 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
 

Each days training will include actual case studies to highlight topics covered, review of applicable forms that can be used as templates for change control, or audit checklists, etc. Attendees will have ample opportunity to ask questions regarding current industry practices or their own company practices.



Speaker Details


Kenneth Christie
Kenneth Christie,
Chief Operating Officer, VTS Consultants Inc and ISPE Examination Development Committee (EDC) Member

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 Amherst, 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.

 

Please contact the event manager Marilyn below for the following: 
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase. 
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS 
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This Event Listing is Promoted by
New York Media Technologies LLC in association
with Metricstream Inc.
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Event Categories
BUSINESS & MANAGEMENT CONFERENCES
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COMPUTERS AND INTERNET CONFERENCES
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Keywords: design , implement, industry , learn, Learning , opportunity, professional, program , sing, benefit




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