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Developing a Validation Master Plan
This Webinar is over| Date | Sep 30, 2014 |
| Time | 01:30 PM EDT |
| Cost | $235.00 |
|
Online
|
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.
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.
Objectives of the Presentation:
To give a better understanding on
Instructor Profile:
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,.
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.
For further details please contact customersupport@onlinecompliancepanel.com or call us on 510-857-5896
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.
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.
Objectives of the Presentation:
To give a better understanding on
- 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?
- Quality Assurance
- Regulatory affairs
- Operations Engineers
- Quality Engineers
Instructor Profile:
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,.
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.
For further details please contact customersupport@onlinecompliancepanel.com or call us on 510-857-5896
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