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Validation and Qualification of SaaS Solutions in GxP Environment

Description

 

Although belief in the value of cloud is widespread, a clear understanding of maintaining validated and controlled state of cloud solutions is often lacking, leading to misguided strategies and faulty implementation or too much validation and documentation; sometimes repeating everything which cloud solution provider has already executed. Selecting the right cloud deployment model or validation strategy can be challenging when considering the various regulations and standards that
apply to the GxP environment, such as 21 CFR Part11, EU Annex11 GDPR, PCI DSS, HIPAA, ISO and many more. This training program will provide comprehensive understanding of topics as listed below.

 

Why you should attend this training?

 

At the end of this course attendees will:

  • Learn basics but elaborative cloud deployment models;
  • Know misconceptions industry has while choosing cloud solutions;
  • Learn difference among IaaS / PaaS / SaaS;
  • Know cloud service provider and regulated industry responsibilities when using Traditional deployment vs cloud deployment for IaaS / PaaS / SaaS;
  • Examine requirements when Planning Cloud Solution Implementation;
  • Learn pre-qualification requirements before contracting with Cloud Service Provider;
  • Learn recommended validation steps to be followed by regulated industry while implementing GAMP Category 3 Cloud Solution;
  • Learn recommended validation steps to be followed by regulated industry while implementing GAMP Category 4 Cloud Solution;
  • Learn recommended validation steps to be followed by regulated industry while implementing GAMP Category 5 Cloud Solution;
VALIDATION AND QUALIFICATION - EARLY BIRD TICKET

VALIDATION AND QUALIFICATION - EARLY BIRD TICKET

EUR599

Livestreaming Zoom _____ ✔️ Interactive Lectures _____ ✔️ FREE Recorded Webinar One Month Access _____ ✔️

16/50

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VALIDATION AND QUALIFICATION - EARLY BIRD TICKET

Who should attend?

Target Audience: This Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and validation of computerized systems.

  • Quality Assurance specialists
  • Technical and IT personnel
  • Validation specialists
  • Technical and IT personnel
  • Business Users
  • All levels of management (IT-Head, CIO, CEO, COO etc. for start-up organizations)

About the trainer

Neeru Bakshi – CSV/IT-QA Advisor

Neeru Bakshi

“Regulatory and technical software is nothing without a team of data and science experts at its core. Neeru is one of those ultra-valuable veteran data experts that digs into the nitty gritty of regulations, guidelines, and systems and makes sure the organization is up to date and on track with any new technical developments in QA, validation or any other industry standards.”

Neeru Bakshi has more than with 20 years’ experience in the pharmaceutical and Life Sciences domain. She worked as Validation/QA Lead, Project Manager/Lead, and as Business Analyst for various cloud solutions and systems such as Oracle Life Sciences Applications for Clinical Trails, SAP, GLP systems, Electronic Submissions, Pharmacovigilance Systems.
Neeru is well versed in regulatory standards and guidelines; 21 CFR Part 11, Computer System Used in Clinical Trials, GAMP5 guidelines, EudraLex Volume 4 Annex11 along with knowledge of European data protection laws and practices and understanding of the GDPR. She has experience and interest executing
harmonization, development and implementation of Global Quality and IT/CSV Policies/ SOP’s/ Guidelines across the organization level. She also has experience in
the pharmaceutical industry audits of validated computer systems, and supporting clients in such pharmaceutical industry audits, whether they be internal audits,
sponsor-driven audits, or regulatory agency audits.


At present Neeru Bakshi is Founder of Tech Qualitas organization where team aims to provide the pharmaceutical, biotech, medical device, CRO and other regulated
companies by providing compliant outsourced services such as for Computerized System Validation, Customized Software Solution, SOP Development & Implementation, Information Technology Services, Audit, Compliance and Data Integrity Support, IT vendor audits on behalf of regulated company, SaaS product
validation to improve performance, data integrity, privacy controls, and compliance.

8:45 am - 9:00 am Online

Connecting to webinar

9:00 am - 9:30 am

Brief Introduction to 21 CFR Part11 Requirements

Overview of Cloud Computing deployment models

9:35 am - 10:20 am Online

Myths About Cloud Solution – Common Misconceptions

Understand benefits and drawbacks of On-Premises Platform vs. Cloud Platform

10:20 am - 10:35 am Online

Coffee break

10:35 am - 11:30 am Online

Operational management of Iaas / PaaS / SaaS

Understand Traditional Validation v/s SaaS Validation

11:30 am - 12:30 pm Online

Cloud Service Provider compliance requirements

12:30 pm - 1:15 pm Online

Lunch break

1:15 am - 2:00 pm Online

Requirements when Planning Cloud Solution Implementation

2:00 pm - 2:30 pm Online

Recommended Validation Approach - GAMP Category 3 Cloud Solution

2:30 pm - 3:00 pm Online

Recommended Validation Approach - GAMP Category 4 Cloud Solution

3:00 pm - 3:45 pm Online

Recommended Validation Approach - GAMP Category 5 Cloud Solution

3:45 pm - 4:00 pm Online

Coffee break

4:00 pm - 5:00 pm Online

Q&A session with trainer

  • Date : May 31, 2023
  • Time : 9:00 am - 5:00 pm (UTC+0)
  • Reg. Deadline : May 17, 2023 12:00 am
  • Venue : North America

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