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PHARMA 4.0: NEXT GENERATION TECHNOLOGY APPROACH TO GXP PRODUCTS, AND FDA
COMPLIANCE

Carolyn Troiano

Thursday,
May 23,2024
Time:
1:00 PM EDT
Duration:
90 Minutes
Event Type :
Live Webinar
Category:
Pharmaceutical
Days Left :
14 Days Left
Overview :

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data,
and FDA Compliance

Best Approach to Validating Computer Systems Regulated by FDA

Aligning an Agile Methodology to the GAMP®5 “V” Model

Advancements in technology have forced organizations to rethink business models.
Once controlled and orderly, these organizations are now more chaotic and
complex, serving patients and customers who are better informed and with higher
expectations than ever before. Work practices and tools must change to meet
these challenges.

The approach to developing software, performing validation, and maintaining a
system in a validated state through its entire life cycle should be carefully
considered in order to meet changing needs. This webinar will include a
comparison of the Agile and Waterfall methodologies, along with the pros and
cons of each. There may not be one size that fits all, so it is important to
understand what needs to be considered when making such a determination.

Learning Objectives:-

 * Learn how to identify “GxP” Systems
 * Learn about FDA’s current thinking about technology and software development,
   and how this will impact the industry
 * Discuss the current state of the Computer System Validation (CSV) approach
   based on FDA requirements
 * Understand traditional CSV as it compares with Computer Software Assurance,
   the latest DRAFT guidance from the FDA
 * Learn about the System Development Life Cycle (SDLC) approach to validation
   and how this can be modernized through a more agile approach, including
   automated testing for continuous validation
 * Learn the pros and cons of an Agile vs. Waterfall approach
 * Learn about cloud computing and Software as a Service (SaaS) systems that can
   be embraced and validated effectively, along with other newer technology
   products, services, and platforms
 * Understand the best practices for documenting computer system validation
   efforts, whether using a Waterfall or Agile approach, including requirements,
   design, development, testing, and operational maintenance procedures,
   including ways to improve the efficiency and effectiveness of managing
   related documentation
 * Understand how to maintain a system in a validated state through the system’s
   entire life cycle in a more cost-effective manner, applying an Agile
   continuous validation approach
 * Learn how to ensure the integrity of data that supports GxP work, despite
   changes and advances in new technology
 * Understand the importance of “GxP” documentation that complies with FDA
   requirements
 * Learn about the policies and procedures needed to support your validation
   process and ongoing maintenance of your systems in a validated state
 * Know the regulatory influences that lead to FDA’s current thinking at any
   given time
 * Finally, understand the industry best practices that will enable you to
   optimize your approach to validation and compliance, based on risk
   assessment, to ensure data integrity is maintained throughout the entire data
   life cycle

Areas Covered:-

 * Computer System Validation (CSV)
 * Computer Software Assurance (CSA)
 * Waterfall Methodology
 * Agile Methodology
 * System Development Life Cycle (SDLC) Methodology
 * GAMP®5 2nd Edition
 *  GAMP®5 “V” Model
 * Automated Testing
 * Critical Thinking
 * Cloud Computing
 * Software as a Service (SaaS)
 * Q&A

Background:-

As part of the Case for Quality program, the US FDA Center for Devices and
Radiological Health noted how an excessive focus by industry on compliance
rather than quality may be diverting resources and management attention toward
meeting regulatory compliance requirements vs. adopting best quality practices.
There has also been a lower-than-anticipated investment in automation and
digital technologies, which could greatly improve quality and process control. A
key element is a risk-based, product quality, and patient-centric approach to
Computer System Assurance (CSA) vs. the traditional Computer System Validation
(CSV) Waterfall approach. This encourages critical thinking based on product and
process knowledge and quality risk management over prescriptive
documentation-driven approaches.

This is where the FDA determined that “WHAT” is required can be done (the “HOW”)
in different ways and does not have to be according to the “checklist” mindset
of most CSV work, where you create documents without specifically addressing the
risk of potential failure of each requirement.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches
including Agile, for the development of custom applications. Keys to success
include a robust Quality Management System and well-trained and highly
disciplined teams following well-defined processes supported by tools and
automation.

Why Should You Attend?

The attendee will learn about FDA’s approach to modernizing technology, and how
that will benefit both the Agency and the industry. We will discuss ways to
modernize the System Development Life Cycle (SDLC) approach to Computer System
Validation (CSV) by using automated testing tools that will result in a
continuous validation of software products. This approach is amenable to the
Agile software development methodology, which can be adapted for use in
validation.

We will also discuss the important aspects of CSV and how to apply them in a new
and modern technological environment.

Who will Benefit?

 * Information Technology Analysts
 * Information Technology Developers and Testers
 * Software Quality Assurance Professionals
 * QC/QA Managers and Analysts
 * Analytical Chemists
 * Compliance and Audit Managers
 * Laboratory Managers
 * Automation Analysts
 * Manufacturing Specialists and Managers
 * Supply Chain Specialists and Managers
 * Regulatory Affairs Specialists
 * Regulatory Submissions Specialists
 * Risk Management Professionals
 * Clinical Data Analysts
 * Clinical Data Managers
 * Clinical Trial Sponsors
 * Computer System Validation Specialists
 * GMP Training Specialists
 * Business Stakeholders/Subject Matter Experts
 * Business System/Application Testers
 * Vendors responsible for software development, testing, and maintenance
 * Vendors and consultants working in the life sciences industry who are
   involved in computer system implementation, validation, and compliance


LIVE VERSION

$229 Live




$599 Corporate Live 1-3-Attendees




$1099 Corporate Live 1-6-Attendees


RECORDED VERSION

$229 Recording




$229 Transcript




$249 DVD


COMBO VERSION

$399 Live & Recording




$399 Recording & Transcript

Refund Policy

* Download the Order Form

* For 6+ attendees call us at + 1 (866) 755-8624 or mail us at
cs@onlineaudioeducator.com

FIND MORE PHARMACEUTICAL WEBINARS

--------------------------------------------------------------------------------

Supervising a Human Error Free Environment: You Can Do a Lot More Than You Think

--------------------------------------------------------------------------------

Instructor:





Carolyn Troiano has more than 30 years of experience in computer system
validation in the pharmaceutical, medical device, animal health, tobacco and
other FDA-regulated industries. She is currently an independent consultant,
advising companies on computer system validation and large-scale IT system
implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many
of the larger pharmaceutical companies in the US and Europe. She developed
validation programs and strategies back in the mid-1980s, when the first FDA
guidebook was published on the subject, and collaborated with FDA and other
industry representatives on 21 CFR Part 11, the FDA’s electronic
record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the
PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a
project management instructor for non-profit organizations.



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cs@onlineaudioeducator.com



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