2-day In-person Seminar

Best Practices for Lean Documentation for Data Integrity, 21 CFR 11, Annex 11 & Computer Systems Validation


May 7th & 8th, 2018

Time: 9:00 AM to 6:00 PM

Zurich, Switzerland

Venue: Hotel NH Zurich Airport


Director : Angela Bazigos

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,895.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $5,685.00
      $9,475.00 You Save: $3,790.00 (40%)*

  Register for 10 attendees   Price: $10,422.00
      $18,950.00 You Save: $8,528.00 (45%)*
Course "Best Practices for Lean Documentation for Data Integrity, 21 CFR 11, Annex 11 & Computer Systems Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The Problem

"Why Do We Need Validation?" is a question that I hear a lot. Yet computerized system validation and its related regulations of data integrity, 21 CFR 11 and Annex 11 are to regulated data what building codes are to houses!! Just like building codes ensure that houses are build to a certain standard where we can rest assured of their quality and safety, so do validation and related regulations ensure that computer systems are implemented to a certain standard of quality and trustworthiness. And just like we would not want to live in a house that is not "built to code" so we would not want to use computerized system that is not "built to regulations".

"Building to regulations" achieves Data Integrity.

Yet every time we must do a validation project we groan and resist. Why is that?

The answer is that validation of computer systems is still widely expected among life science professionals to be very expensive and time consuming and to slow down the deployment of new functionality that may be needed by the company's business growth. For example, traditionally most pharmaceutical companies deploy on-premise software. They may purchase a commercial off-the-shelf (COTS) system, install it internally on servers, configure it to communicate on the corporate network and with other systems and databases and manage it in compliance with a corporate IT strategy and set of SOPs. Aside from the COTS development of the COTS software package, everything is owned, managed and maintained by the company. This results in significant costs to the company, which includes applying patches, administering the internal network connections, securing the data, creating disaster recovery contingencies and the capital-intensive nature of keeping the required hardware viable. The expense and capital burden of the on-premise model in many companies is nothing to the inherently slow pace of deploying functionality to the business. IT projects continue to back up as IT teams shrink and the needs of the business grow.

Add to that the amount of documentation that is generated by these activities foists additional burden to redoing these activities.

Plus, use of recent technologies such as cloud where the vendor takes partial control and uses automation techniques to update features and functions is at odds with the current validation processes.

So, how do we meet the same level of quality of complying with regulations and GAMP 5, while taking advantage of technologies such as cloud and SaaS implementations? How do we keep up with the latest technologies while ensuring the quality of computer systems and that they are "built to regulations" to achieve Data Integrity?


The Seminar:

This hands-on seminar will describe how the company can speed up validation and keep up with recent technologies while still implementing a rigorous computerized system compliance program. This is done by using the methodology enhancers of risk management, lean documentation and automated testing. The way to achieve rigorous compliance, build computerized systems to regulations and use of techniques to cut back on the validation effort will be explained. The use of exercises to include a project attendees are currently working on as well as a Jeopardy style quiz to test the attendees' knowledge, will ensure maximum retention of the concepts and practices.

At the end of this seminar the attendees will be able to:

  1. Master the principles and regulations that achieve data integrity by applying the 21 CFR 11 / Annex 11 and GAMP 5 validation of computerized systems regulations to computerized systems
  2. Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity
  3. Explain automated testing best practices how to select automated testing vendors to ensure that use of vendor tools allows for the flexibility to use Cloud / SaaS / IaaS / PaaS related technologies while maintaining data integrity
  4. Explain how to use Hardware Qualification and Change Control to manage both internal network and infrastructure as well as vendors such as cloud providers

Who Should Attend:

  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for DATA INTEGRITY / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior Directors of Discovery
  • Directors / Senior Directors of Development
  • Directors / Senior Directors of Commercialization
  • Document Managers
  • Training Managers
  • Consultants
  • Data Managers
  • Safety Managers

Industries:

  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Hospitals
  • Healthcare
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia
  • Agricultural
  • Software vendors
  • Cloud providers

Day 1 Schedule


Lecture 1:

Best Practices

  • Best Practices of Lean
  • Best Practices of Lean Documentation
  • Best Practices of Automated Testing

Lecture 2:

The Regulations and What They expect, not just what they say

  • Data Integrity
  • 21 CFR 11
  • Annex 11
  • GAMP 5 & Computer Systems Validation

Lecture 3:

Selecting and Managing the Vendors

  • Vendor Selection for automated testing
  • Vendor Audits - if the vendor does not do it in a compliant manner, then you must do it!!
  • Risk Assessment for the System
  • Risk Assessment for Requirements

Lecture 4:

GAMP5 Deliverables: Validation Plan & Requirements

  • Validation Plan
  • Gathering Requirements
  • Entity Relationship Diagram
  • Process Decomposition
  • Exercise to create Lean Requirements

Day 2 Schedule


Lecture 5:

GAMP5 Deliverables: Design

  • Design Specifications
  • Software Configuration and Build
  • Exercise to create Lean Design Specifications

Lecture 6:

GAMP5 Deliverables: Verification & Testing

  • Traceability Matrix
  • Verification and Testing
  • Other Documents
  • Exercise to create Lean Test Cases
  • Automated Testing

Lecture 7:

Hardware Qualification

  • Equipment Qualification
  • Infrastructure Qualification
  • SaaS / PaaS / IaaS & Cloud Qualification
  • Automated Testing

Lecture 8:

Change Control & SOPs

  • Change Control
  • Change Control & SLAs for Cloud Vendors
  • SOPs

Jeopardy Quiz: Lean Documentation for Data Integrity / 21 CFR 11 / Annex 11 Compliance in Cloud Based IT Systems

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Angela Bazigos is the CEO of Touchstone Technologies Inc. and has 40 years of experience in the Life Sciences, Healthcare & Public Health Services. She has extensive experience in Computer Systems Validation and Data Integrity including having collaborated with FDA on prototyping 21 CFR 11 in 1992-1995, patent on using virtualization to speed up validation and a book on computerized systems in clinical research co-authored with FDA and DIA . She has successfully completed 56 large validation projects with a 94% on-time / on budget record.

Ms. Bazigos has degrees in Microbiology and Computing which she has used for her wide experience. Her experience includes Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer , Director of QA and MIS Director. Interviewed by Wall Street Journal on using training to bring regulatory compliance to the Boardroom . Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences :.

https://www.google.com/patents/US8266578

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx

http://morflearning.com/angelabazigos/

http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview

Location: Zurich, Switzerland Hotel: Hotel NH Zurich Airport   Schaffhauserstrasse 101, 8152 Glattbrugg, Switzerland

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