developing a validation master plan

1. Developing a Validation Master PlanWho can Benefit:Quality AssuranceRegulatory affairsOperations EngineersQuality EngineersOnlineCompliancePanel LLC | 38868 Salmon Ter, Fremont California 94536 USA| 510-857-5896 [email protected]

2. 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 [email protected] 3. Description of the Webinar :This course will provide a step-by-step guidance for medical device companies thatneed 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 validationrequirements for each test/ system/ equipment and will guide the organization inachieving its objectives.OnlineCompliancePanel LLC | 38868 Salmon Ter, Fremont California 94536 USA| 510-857-5896 [email protected] 4. Why Should you Attend :This course will provide guidance on bestpractices for developing andimplementing a good plan detailingresponsibilities, and deliverables to makevalidation efficient, and consistent.OnlineCompliancePanel LLC | 38868 Salmon Ter, Fremont California 94536 USA| 510-857-5896 [email protected] 5. Instructor Profile:Marie DoratCEOIPRF, LLCMarie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in thePharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established andstart-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 & IVDindustry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held anumber of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured atconferences 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 withinternational new product registrations as well as rebranding products after an acquisition or merger. She has developed aprocess to reduce time to market for most companies by several months. She provides training courses both for publicgroups and in-house on topics including: International Product Registration project management, Auditing 101, Writing andmanaging Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to PrepareOnlineCompliancePanel LLC | 38868 Salmon Ter, Fremont California 94536 USA| 510-857-5896 [email protected] 6. About OnlineCompliancePanel :Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and costeffective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holisticand effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on variedtopics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of ourprimary 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. OnlineCompliance Panel believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services aredesigned to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering originaland creative content.Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. Online Compliance Panelclosely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed inFDA, 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 stemfrom comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified andexperienced 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 onoffer .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 [email protected] 7. Developing a Validation Master PlanRegistration Link : http://bit.ly/ValidationMasterPlanFor further details contact [email protected] call 510-857-5896OnlineCompliancePanel LLC | 38868 Salmon Ter, Fremont California 94536 USA| 510-857-5896 [email protected]

developing a validation master plan

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