The document details a 2-day seminar focused on effective change control programs and addressing out-of-specification (OOS) results, led by Kenneth Christie, an expert with over 30 years of experience in regulatory GMP consulting. The seminar, priced at $1,295 per delegate with early bird discounts available, covers regulatory requirements, common industry challenges, and best practices for change control procedures. Participants from various sectors, including quality assurance and regulatory personnel, can benefit from interactive sessions, networking opportunities, and practical insights to improve quality systems.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
The Challenges of an Effective Change
Control Program and How to Address OOS Results
San Diego, CA
9:00 AM to 6:00 PM
Kenneth Christie
Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
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.
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.
$6,475.00
Price: $3,885.00 You Save: $2,590.0 (40%)*
Register for 5 attendees
August 17th & 18th, 2017

2. 2-day In-person Seminar:
The Challenges of an Effective Change Control Program
and How to Address OOS Results
Agenda:
Day One Day Two
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.
Global
CompliancePanel
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.
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.
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 results (OOS)
Lecture 4: 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.
Who Will Benet:
 Quality Assurance
 Quality Control
 Manufacturing
 Production
 Regulatory
 Laboratory Personnel
 Management
 Equipment Vendors
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.

3. Media Partners
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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Global
CompliancePanel
2-day In-person Seminar:
The Challenges of an Effective Change Control Program
and How to Address OOS Results