2 Days Workshop Current regulatory thinking on Data Integrity in 2020

By: Chinmoy Roy, BSEE, MSCS US FDA Expert Data integrity & CSV.
Product code: SEM62
Location 1: Philadelphia May 11 - 12

Description

Course “2 Days Workshop Current regulatory thinking on Data Integrity in 2020" 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 Tuition per attendee includes the two-day workshop, all workshop materials, continental breakfast and lunch both days provided by WCS"

Data integrity continues to be one of the topmost concerns of regulators worldwide.  With regulatory agencies actively hiring computer savvy personnel, we can only expect increased and rigorous audits of data integrity. 

This intermediate level workshop focuses on emerging data integrity concepts and audit focus areas. Attending this workshop will enable attendees to not only become familiar with data integrity fundamentals and practices but to also effortlessly identify and remediate potential data integrity issues before auditors do.

Addressed will be case studies, inspection approaches, trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This intermediate level workshop is for experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements.  These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc.

Areas Covered

  • Understand existing USFDA and EU GMP regulations and guidance for data integrity
  • Learn requirements for a Data Governance program and Data Integrity Assurance plan
  • Learn how to link data lifecycle to process centric data integrity business processes
  • How to continually monitor and improve Data Integrity impacting business processes
  • Data Life Cycle design and controls
  • Elements of a Data Integrity Assurance program

 

Some advanced Data Integrity topics include:

  • Roles and responsibilities of different groups in ensuring data integrity
  • What data integrity SOPs do auditors expect to see during audits
  • What is the Data Integrity triad
  • How to validate Data Integrity impacting business processes
  • Data Integrity Maturity Model
  • Developing critical thinking skills
  • Data Integrity Audit trends

Who will Benefit

  • Executive management
  • Regulatory affairs
  • Quality assurance/quality control
  • Legal and compliance officers
  • Clinical research directors
  • Consultants/service providers
  • CAPA specialists
  • Compliance information managers
  • GMP compliance officers
  • GMP training managers
  • Heads of internal audits
  • QA documentation managers
  • QA/QC managers and directors
  • Quality systems managers
  • Systems analysts
  • Training personnel

Learning Objectives

Course Outline:

08:30 AM

Module 1 - Setting the scene: importance of DI

  • Compendium on DI
  • What are the principles of DI
  • Navigating the maze of DI guidance – which guidance to use for what
  • Summary of DI observations to date

Break

Module 2 – Why Data Integrity issues occur

  • What are the top 5 misconceptions of DI
  • What are the 5 ways to detect DI issues
  • 5 ways to prevent DI issues to occur
  • What is the Controls Triad for DI
  • Mitigating the single most DI factor: Human behavior and their drivers

Lunch Break

Group exercise: Assessing a system for DI

  • Using a checklist for different types of assessments
  • Group suggests solutions for real world case studies detected during field audits

Break

Module 3 - Addressing specific DI issues

  • Raw Data management – why significant, applicable predicate rule, DI guidance
  • Laboratory Controls – what is it, its predicate rule and Table of Contents of its SOP
  • Audit Trail Review – DI significance and Table of Contents of its SOP
  • Implementing a Data Integrity remediation Plan – Identifying DI gaps using Gemba walks along with their remediation
  • Special considerations for Data Integrity Risk assessment using DI Life cycle and Process Flow charts

 

08:30 AM

Module 4 – Recipe for DI success: a process centric approach

  • What is a process centric approach
  • What is Cultural excellence and what are its 6 dimensions
  • Understanding deviant human behaviors and how to address them proactively

Break

Module 5 – Data Integrity issues in the cloud

  • Regulatory compliance requirements for Cloud use
  • Sharing DI responsibilities for Cloud use
  • Data Integrity audit of GxP supplier of Cloud services using SOC 2 process
  • Validation of DI for Cloud use
  • Applying FDA’s “Case for Quality” for Cloud use

Lunch Break

Module 6 – Implementing Data Integration remediation at a existing facility

  • Setting up for success: Critical factors to consider for team formation
  • GEMBA walk checklist
  • Guidance on how to mitigate DI gaps in existing equipment/systems

Break

Module 7 - Data Integrity by Design and Pharma 4.0

  • What is the digital manufacturing model
  • Critical Role of IT in ensuring Data Integrity in Pharma 4.0
  • Organization’s essential Data Integrity Maturity elements for migrating to Pharma 4.0

 

speaker

Chinmoy RoyBSEE, MSCS US FDA Expert Data integrity & CSV

Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems

Has 35+ 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 hands-on field experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at as well as consulted with leading companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in leading and implementing a paperless 21 CFR 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 has a Masters degree in Computer Science.

11-May-2020 To 12-May-2020 Philadelphia
Seminar One Registration
$ 1497 (Early Bird Till 28 March )



Special Group Discount Register for Four attendees
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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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