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 1. Home
 2. Seminar
 3. Change Control Best Practices - Avoiding Unintended Consequences of Changes


2-Day Virtual Seminar


CHANGE CONTROL BEST PRACTICES - AVOIDING UNINTENDED CONSEQUENCES OF CHANGES




By:
Michael Ferrante, President, Quality and Compliance Associates LLC

Course ID: 80244SEM



1

SIMU LIVE

(On-demand Streaming - Virtual Training Through WebEx)


$1499*
Simu Live : On-demand Streaming
Virtual Training Through WebEx

Recorded On: May, 2024

Buy Now
Download Brochure

 

 * Course Description
 * Agenda
 * Speaker
 * Price/Register
   
   

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change
control. Change control receives detailed scrutiny during FDA inspections, and
FDA reviews change control documentation to determine that changes did not
adversely impact products, processes, equipment, facilities, etc. A single
inadequate change may lead to significant negative events, including release of
sub-standard product or product recall. A pattern of inadequate changes may
require costly and time-consuming system remediation efforts.

It is therefore critically important to assure that changes are properly
described, justified, assessed for risk, implemented, and documented. Changes
must also be prospectively reviewed by appropriate subject matter experts.
Furthermore, certain major changes (e.g. manufacturing, specifications) may
require regulatory filings and/or prior regulatory approval.

This seminar will help all personnel involved in proposing, assessing, and
implementing changes to understand and successfully apply Change Control best
practices. Key focus will be placed on change proposals, justification / risk
assessment and change execution / implementation. The importance of proper
planning, critical thinking skills, and co-ordination of all change activities
will also be discussed. Techniques for assuring robust Change Control programs
in light of COVID-19 restrictions will also be discussed.

This is a practical how-to course, designed to provide participants with skills
they can immediately apply to change controls within their own organizations.
Case studies will allow participants to practice skill sets in cooperation with
the instructor.




LEARNING OBJECTIVES:

Upon completing this course, participants should be able to:

 * Understand the purpose of change control
 * Understand regulatory requirements and FDA expectations for change control
 * Identify what types of changes are /are not subject to change control
 * Properly describe changes
 * Properly justify changes
 * Develop a comprehensive Change Execution Plan
 * Conduct a proper change Risk Assessment
 * Ensure proper execution of changes
 * Ensure proper implementation of changes
 * Develop a complete Change Control documentation package
 * Utilize critical thinking skills throughout the change control process
 * Avoid pitfalls during the change control process

Seminar Fee Includes:
Seminar Material
Copy of presentation
Attendance Certificate
Download Brochure




WHO WILL BENEFIT:

This course is designed for people tasked with:

 * Authoring change proposals
 * Assessing / approving change proposals
 * Executing / implementing changes

The following personnel will benefit from the course:

 * Change proposal authors
 * Reviewers / approvers of change controls
 * Change control system owners
 * Production staff / management
 * Engineering staff / management
 * Validation staff /management
 * QC staff / management
 * Regulatory Affairs staff / management
 * QA staff / management

This course is designed from a pharmaceutical manufacturing perspective;
however, since the main focus is on techniques and practices, the course
material may be equally applied to biologics and medical device environments.
Please note that this seminar focuses on changes to equipment, facilities,
materials/components, test methods, suppliers, specifications, etc. Document
Change Control is discussed as a supporting element; however, it is not the main
focus.


Register by phone or need assistance? Call +1-888-717-2436 Register Now Download
Brochure
Day 01(8:00 AM - 2:00 PM PT)


 * Regulatory Requirements
 * FDA Change Control Expectations / Warning Letter Examples
 * Purpose of Change Controls
   * What is Change Control?
   * Why / When Change Control?
   * Physical Changes vs. Document Changes
 * Change Control Process
   * Change Control Process Model- Integrated Manufacturers
   * Change Control Process Model- Sponsor Oversight of CMO Changes
 * Types of Changes Subject to Change Control
   * Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
   * Like-for-Like Changes
   * Emergency Changes
   * Case Study # 1- Change Control: Yes or No?
 * Change Proposal
   * Change Proposal Elements
   * Describing the Change
   * Case Study # 2- Change Proposal
 * Change Justification
   * Change Justification Elements
   * Change Risk Assessment
   * Case Study # 3- Change Justification
 * Change Execution Plan
   * Change Execution Plan Elements
   * Case Study # 4- Change Execution Plan
 * Change Proposal Assessment
   * SME Assessments (by functional area)
   * Case Study # 5- Change Proposal Assessment


Day 02(8:00 AM - 2:00 PM PT)


 * Change Execution
   * Key Considerations for Executing Changes
   * Evidence of Change Completion
   * Change Amendment / Cancellation
 * Change Implementation
   * Key Considerations for Implementing Changes
   * Assessing Change Effectiveness
 * Change Control Documentation
   * Change Documentation Package Elements
 * Putting It All Together: A System Viewpoint



Register by phone or need assistance? Call +1-888-717-2436 Register Now Download
Brochure


Michael Ferrante
President, Quality and Compliance Associates LLC

Mr. Ferrante is President of Quality and Compliance Associates LLC and has over
40 years experience in the pharmaceutical and biotechnology fields. This
experience encompasses quality systems, laboratories, R&D, clinical QA,
validation, manufacturing/operations, regulatory affairs, and facilities
covering all dosage forms.

During his career, Mr. Ferrante has successfully dealt with over 100 inspections
by regulatory agencies, resolved warning letters, prepared and controlled
compliance plans at both a site and corporate level. These interactions have
occurred both domestically (US) and internationally, since he has dealt in
global operations in countries such as Australia, Canada, the Netherlands,
Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech
Republic, India, China, Malaysia, and Thailand.

He has held middle to senior management positions in startup to Fortune 100
companies up to the level of VP of Quality Systems and Compliance. Mr. Ferrante
has been asked to give presentations on a number of regulatory and quality
topics by the American Society for Quality, the Parenteral Drug Association,
International Society of Pharmaceutical Engineers, and the Institute for
Validation Technology. He has published articles in the Journal of Validation
and Journal of Compliance.


Register by phone or need assistance? Call +1-888-717-2436 Register Now Download
Brochure


REGISTER NOW


 * 1
   Simu Live
   (On-demand Streaming)


ONLINE USING CREDIT CARD

$1,499.00


(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)

$7,999.00


Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)




OTHER REGISTRATION OPTION

By order form / PO#
 * Download the Order Form
 * Fill this form with attendee details & payment details
 * Fax it to +1-650-362-2367, or
 * Email it to customercare@complianceonline.com




PAYMENT MODE

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail
the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.


TERMS & CONDITIONS TO REGISTER FOR THE SEMINAR/CONFERENCE/EVENT

Your registration for the seminar is subject to following terms and conditions.
If you need any clarification before registering for this seminar please call us
@ +1-888-717-2436 or email us @ customercare@complianceonline.com




PAYMENT:

Payment is required 2 days before the date of the conference. We accept American
Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our
parent company).




CANCELLATIONS AND SUBSTITUTIONS FOR IN-PERSON SEMINARS:

Written cancellations through fax or email (from the person who has registered
for this conference) received at least 10 calendar days prior to the start date
of the event will receive a refund - less a $300 administration fee. No
cancellations will be accepted - nor refunds issued - within 10 calendar days
before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid
minus administration fees ($300) will be transferred to any future
ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite,
payment to happen through credit card immediately or check to be submitted
onsite. Conference material will be given on the spot if it is available after
distributing to other attendees. In case it is not available, we will send the
material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not
responsible for any airfare, hotel, other costs or losses incurred by
registrants. Some topics and speakers may be subject to change without notice.




CANCELLATIONS AND SUBSTITUTIONS FOR VIRTUAL SEMINARS & WEBINARS:

Written cancellations through fax or email (from the person who has registered
for the training) received at least 10 calendar days prior to the start date of
the event will receive a refund — less a 30% administration fee. No
cancellations will be accepted — nor refunds issued — within 10 calendar days
from the start date of the event. On request by email or fax (before the
training) a credit for the amount paid minus administration fees (30%) will be
transferred to any future ComplianceOnline event and a credit note will be
issued. Substitutions may be made at any time. No-shows will be charged the full
amount. Some topics and speakers may be subject to change without notice.

Offers: Early bird seats are limited and based on first-come, first-serve.
Multiple offers cannot be combined.



WE NEED BELOW INFORMATION TO SERVE YOU BETTER

Name:* Email Address:* Phone number:* Job Title:* --------------------- Select
One ------------------ Accountant & Finance Manager Administrator
Analyst/Specialist/Associate Buyer/Planner CEO/President/Board of
Directors/Principal CFO/Treasurer Chief Compliance Officer Chief Risk Officer
CIO/CTO/COO Clinician/Lab Manager Consultant Controller/Comptroller
Director/VP/EVP Engineer Executive/Admin Assistant General Counsel
Manager/Supervisor/Coordinator Others


 





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