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Réf : 27116
Evènement :2018 Data Integrity Seminar : FDA/EU Requirements and Implementation

Dates :Jeudi 11 Octobre 2018 - Vendredi 12 Octobre 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Formation - Audience Internationale

Accréditation :--



2018 Data Integrity Seminar : FDA/EU Requirements and Implementation

Location 1: Boston,MAOct 11 - 12



Data Integrity audits project a moving goal post.  Issues that were top warning letter vote getters have made way for newer ones to include Cybersecurity etc. Our Data Integrity courses which are offered around the world are renowned for addressing such evolving trends.  Consequently, they have attracted record attendances.  Attendee feedback suggests the uniqueness of our offerings.  Particularly significant is the feedback from those who attended similar courses offered by other companies.

Chinmoy Roy, our course instructor, is one of the world’s first to design, implement and obtain “fit for use” certification for the world’s largest paperless biologics manufacturing facility in the late 1990s. He is a practicing Data Integrity auditor.  Former FDA inspectors include him on their 3rd party and mock audit teams.  His also continues to provide consulting services in the design and implementation of Data Integrity infrastructures to major multinational companies.  His lucid and pragmatic presentation style and interaction with the trainees/conference attendees, has earned him the “Speaker of the year” award from attendees of the world’s prestigious conference on Data Integrity. 

In Chinmoy’s words: “I design my trainings to ensure that trainees take away concepts that prepares them to play strong leadership roles in improving the data integrity governance and management in their organizations.  Based on my field experience in this area lasting well over 20 years, I want this course to help you answer the toughest questions in Data Integrity that your organization may be faced with and thereby enable you and your company to remain a step ahead in your industry.”

The training will address case studies, inspection approaches and trends. Take back to your work, samples of Data Integrity related directives and SOPs. This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. 

Areas Covered

•      What is Data integrity
•      Data Life Cycle design and controls
•      Elements of a Data Integrity Assurance program
•      Roles and responsibilities of different groups in ensuring data integrity
•      What data integrity SOPs do auditors expect to see during audits
•      Validating Data Integrity

Who will Benefit

•       Pharmaceutical industry / Medical device industry / Healthcare industry personnel
•       Developers of software for use in Life Sciences industry
•       Validation service providers, IT service providers
•       Manufacturing personnel, Manufacturing Automation system vendors and system integrators
•       Regulatory Affairs group, Quality Unit
•       Laboratory personnel
•       Users of Cloud
•       Clinical Trial Sponsors

Learning Objectives

•       Some advanced Data Integrity topics include:

        •       Data Integrity triad
        •       Data Integrity Maturity Model
        •       Developing critical thinking skills
        •       Data Integrity Audit trends 


Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.

His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate.


Seminar One Registration |$ 1295 Special Group Discount Register for Four attendees |$ 3995











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2018 Data Integrity Seminar : FDA/EU Requirements and Implementation Pharmacie
• elements of a data integrity assurance program
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