2018 Data Integrity Seminar : FDA/EU Requirements and Implementation (Boston, United States - October 11-12, 2018)

  • ID: 4523327
  • Training
  • Location: Boston, United States
  • 2 Days
  • World Compliance Seminar
  • Training Dates: October 11-12, 2018
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This Course has Been Pre-Approved by RAPS as Eligible for up to 12 Credits Towards a Participant's RAC Recertification Upon Full Completion

Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee

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.

Learning Objectives

Some advanced Data Integrity topics include:

  • Data Integrity triad
  • Data Integrity Maturity Model
  • Developing critical thinking skills
  • Data Integrity Audit trends
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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
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Day One (8:30 AM - 4:30 PM)

Module 1

Data Integrity Fundamentals:

  • Data types with examples
  • The meaning: raw data, metadata, aberrant data
  • The attributes

Module 2

Primer on 21 CFR Part 11:

  • 21 CFR Part 11 and Annex 11 fundamental concepts and differences
  • FDA’s current thinking on Part 11
  • Why is Part 11 and Annex 11 not the same as Data Integrity

Breakout group exercise: Mapping DI to Part 11

Module 3

Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS:

  • How do these multiple guidance apply to different situations
  • What are the similarities and differences between the guidance

Module 4

How to conduct a Data Integrity Risk Assessment:

  • How is Data Integrity risk assessment different from ICH Q9 risk assessment
  • Critical thinking skills for an effective Data Integrity risk assessment
  • Factors to be considered when establishing scoring criteria Data Integrity risk assessments
  • Mitigation of identified risks to Data integrity and Cyber security

DAY TWO (08:30 AM to 04:30 PM)

Module 5

Using the “Least burdensome approach” to implement DI:

  • What is the “Least Burdensome Approach”
  • Why DI issues occur and how to avoid them proactively
  • DI implementation plan: the 5p model and the Controls Triad
  • What DI SOPs do auditors want to see and what should their contents be

Module 6

Data Integrity for Specialist:

  • IT specialists’ role in designing IT system architectures to ensure DI
  • Laboratory Data Integrity issues and controls
  • Data integrity issues in Clinical Trial Systems
  • Data integrity issues in mobile computing and cloud
  • Using critical thinking skills and effective tools to address OOS, OOT etc.
  • How to address Cyber security issues and evolving regulations for Data quality
  • What data integrity items to review for during a Electronic Batch review
  • GDPR regulation and its relation to Data Integrity

Module 7

How is Data Integrity audited:

  • Developing a Data Integrity audit protocol/checklist
  • Critical thinking skills for Internal Auditors
  • How can you effectively use your Data Integrity Maturity Model during audits

Module 8

Review of Data Integrity and Warning letters:

  • Identify Data Integrity audit trends
  • FDA’s new approaches to data integrity audits
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  • Chinmoy Roy Chinmoy Roy,
    Freelance Consultant ,
    CSV, Data Integrity and Manufacturing Automation specialist


    Chinmoy Roy has 40+ years of experience in the US Life sciences industry. He is an internationally recognized Subject Matter Expert (SME) in Data Integrity, CSV, CFR 21 Part 11, Annex 11 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. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training.

    He was one of the early implementers of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and Validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech, was a precursor to FDA's issuance of Part 11's Scope and Application guidance in 2003.

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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
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ADDRESS

Hilton Garden Inn Boston Logan Airport
100 Boardman St
Boston
MA 02128
United States

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