Developing a Validation Master Plan

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Developing a Validation Master Plan
Who can Benefit Quality Assurance Regulatory
affairs Operations Engineers Quality Engineers
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Objectives of the Webinar

• What is a VMP and how is it valuable to my
  company?
• What topics are covered in the VMP and to what
  extent?
• How is the VMP controlled and updated?
• How is the VMP implemented?
• Who contributes to the VMP?

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
3
Description of the Webinar
This course will provide a step-by-step guidance
for medical device companies that need to develop
a Validation Master Plan (VMP) for
product/equipment transfer, facilities, and
processes or to develop a company standard. The
Validation Master Plan describes the way an
organization approaches validation that controls
the various aspects of the validation activities
and how production, quality, and management will
be involved. The VMP also details the validation
requirements for each test/ system/ equipment and
will guide the organization in achieving its
objectives.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Why Should you Attend
This course will provide guidance on best
practices for developing and implementing a good
plan detailing responsibilities, and deliverables
to make validation efficient, and consistent.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
5
Instructor Profile
Marie Dorat CEO IPRF, LLC
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP
Training and International product registration
Consultant in the Pharmaceutical/Medical Device
IVD Industry She also is the CEO of IPRF, LLC
which specializes in helping established and
start-up companies process the necessary
documents for international product
distribution.Ms. Dorat has 13 years experience
in quality assurance and regulatory affairs in
the pharmaceutical/Medical Device IVD industry,
including auditing clinical trials,
manufacturers, and distributors in the US and
internationally. She has held a number of senior
QA/RA positions. She has worked for several
companies including Pfizer, and Alere She has
lectured at conferences and provides on-site
training courses on QA and GxP issues.She has
also worked directly with various companies in
the Pharmaceutical Medical Device industry,
assisting with international new product
registrations as well as rebranding products
after an acquisition or merger. She has developed
a process to reduce time to market for most
companies by several months. She provides
training courses both for public groups and
in-house on topics including International
Product Registration project management, Auditing
101, Writing and managing Quality Systems, GCP ,
Regulatory requirements for Clinical Trials, FDA
audit and EU inspection- How to Prepare
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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About OnlineCompliancePanel
Online Compliance Panel creates and delivers
comprehensive industry relevant training
sessions. These sessions are simple, interactive
and cost effective. We are a predominantly web
based information exchange forum. Live
interactions on compliance training make the
process holistic and effective. Online Compliance
Panel largely emphasizes in offering regulatory
compliance training to compliance professionals
on varied topics. These primarily include risk
management, quality management, corporate
compliance and other regulatory compliances. Some
of our primary areas of focus include advancement
and updates in regulatory compliance, best
practices and market trends.We strive to
incorporate high standards in developing a
culture facilitating exchange of ideas resulting
in functional excellence. Online Compliance Panel
believes in nurturing ideas and thought processes
through innovative e-learning methodologies. Our
products and services are designed to offer
customized solutions to industry and market. We
bridge the gap between experience and knowledge
thus delivering original and creative
content.Our objectives of employing interactive
mediums ensure effective communication and mutual
exchange of ideas. Online Compliance Panel
closely follows best practices and regulatory
trends in the global compliance scenario. We also
observe and communicate trends witnessed in FDA,
ISO regulations, process and design validation.
All updates and additions to important laws can
be accessed by our customers in real time.Our
mission is to empower compliance professionals
through effective online training sessions. Our
world class training methodologies stem from
comprehensive understanding of client
requirements. The content conforming to FDA and
ISO standards is developed by well qualified and
experienced industry leaders. Our offerings will
exceed expectations and add value to your
investment.The content in various categories
such as medical devices, pharmaceuticals and
biotechnology will raise the bar in terms of
quality already on offer .We hope to contribute
to the creation of responsible organizations
creating benchmarks in quality, integrity and
transparency.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Developing a Validation Master Plan
Registration Link http//bit.ly/ValidationMaster
Plan For further details contact
customersupport_at_onlinecompliancepanel.com or
call 510-857-5896
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com