$972 – $1,285

San Diego 2 Day Seminar Assuring Data Integrity in the Life Science industr...

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Hilton Garden Inn San Diego/Del Mar

11025 Vista Sorrento Parkway

San Diego, CA 92130

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Description

Description

Course “2017 Assuring Data Integrity in the Life Science industry“ 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 provided by WCS""

Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.

This training focuses on implementing Data Integrity programs using “the least burdensome” approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investigations among many others.

Addressed will be case studies, inspection approaches, and 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 workshop is for novices as well as 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

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

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 ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee 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.

After successful workshops last year that filled to capacity, WCS is again teaming up with Chinmoy Roy to provide this all new 2-day workshop. It 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 workshop is for novices as well as 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.


Course Outline:

DAY ONE (08:30 AM to 05:00 PM)


Module 1

Data Integrity: concepts, requirements, definitions, approaches

-Meaning and principles of DI

-Data types and their relevance to DI

-DI dimensions


Break 1


Module 2

Why Data integrity issues occur

-What are the principal factors that cause DI issues to occur

-How to proactively control these factors

-Hands on: Access security & Audit Trail SOP/Directive


Lunch Break


Group exercise: DI Directives & SOPs



Module 3

Implement enterprise DI program

-What is the 5p model for DI

-DI checklist to assess DI health

- What are the DI triad elements



Break 2

Module 4

In the trenches - implementing DI

-What should a company’s DI Assurance Plan contain

-What would auditors like to see in the DI directives & SOPs

-What should a guidance document on how to design for and validate DI contain


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

Module 5

Data Integrity in the Laboratory

-Why laboratory DI is the key focus

-What are Lab DI audit trends & how to avoid them

-What laboratory DI core documents that you need to keep ready for auditors



Break 1

Module 6

DI in Manufacturing IT & Clinical trial systems

-How does Sys. Architecture impact DI

-What are the DI citations for DI items review in Electronic Batch records

-DI susceptibilities of hybrid systems

-Paper and eCRF data entry practices

-What should be aware of when presenting pdf copies to regulators

Lunch Break

Group exercise: Mock inspection audit



Module 7

Advanced topics

-How can you effectively use your Data Integrity Maturity Model during audits

-Critical thinking skills for internal auditors

-What items are critical for DI audits of Clouds; SaaS/PaaS



Break 2

Module 8

Update on current DI audit and enforcement trends using most recently issued 483’s and Warning letters


Presentation of certificates



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.


Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


speaker

Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou.


speaker

Benefits of enrolling for Media Partner

Your company Logo on all the mailings before and after the event.

Get 10% discount to media partner's subscribers.

Publish your Logo and company data on the event website.

Publish your Logo on the conference material distributed during the conference.

Media Partner’s brochure distributed along with conference material


speaker

MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS event in the event calendar, both printed and/or online.

Announcement article of the conference on the Magazine and/or Website.

Dedicated email blast to all subscribers

Sponsors

Top Sponsors for WCS - World Compliance Seminars


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If you wish to sponsor our event

Please contact us:

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


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$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases

Listing in monthly Community Leader newsletter sent to over 50,000 users.

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


speaker

$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases

Listing in monthly Community Leader newsletter sent to over 50,000 users.

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session



Boston Public Garden, Boston,MA

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library, Boston,MA

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessib

Fenway Park, Boston,MA

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right<

Museum of Fine Arts, Boston,MA

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyp

Museum of Science, Boston,MA

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space trave

North End, Boston,MA

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church, Boston,MA

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Pa


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

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.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

Hilton Garden Inn San Diego/Del Mar

11025 Vista Sorrento Parkway

San Diego, CA 92130

View Map

Refund Policy

No Refunds

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