CSV vs CSA - Waterfall vs. Agile Methodology, Documentation

AGENDA:

DAY 1 (10 AM to 3 PM)

Identifying “GxP” Systems
Current state of CSV approach based on FDA requirements
Agile approach to System Development Life Cycle (SDLC)
Pros and Cons of an Agile vs. Waterfall approach
Cloud computing and Software as a Service (SaaS) systems
Agile continuous validation approach
Policies and procedures needed to support your validation process
Q&A

DAY 2 (10 AM to 3 PM)

CSA Gap Assessment
Keys to a Successful CSA Implementation
Documentation using a Waterfall or Agile approach
Implementing CSA Across the organization – Avoiding disorientation
Applicability of CSA Guidance to Data Integrity
IT Supplier Assessments While Adopting CSA Principles
Risk Assessment to optimize your validation approach
Q&A

About The Course:

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 that 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 seminar 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, and so it is important to understand what needs to be considered when making such a determination.

As part of the Case for Quality program 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 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 crank out documents without specifically addressing the risk of potential failure of each requirement.

GAMP5 supports the use of incremental, iterative, and evolutionary approaches including Agile, for 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 You Should Attend :

The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and 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.

SEMINAR OBJECTIVES

WHO SHOULD ATTEND

“GxP” Systems
Computer System Validation (CSV)
Computer Software Assurance (CSA)
System Development Life Cycle (SDLC)
CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
Develop a cohesive and comprehensive validation rationale
Comprehend a risk-based validation technique
Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom developed systems
Learn how to apply an agile methodology to implementation and validation work, including automated testing
Learn best practices for documenting validation, both for a traditional CSV and an agile approach
Maintain a system in a validated state
Learn about continuous validation through automated testing
Assure the integrity of data that supports GxP work
Policies and procedures needed to support validation
FDA’s current thinking and trends
FDA inspection or audit preparation
Vendor Audit
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
Q&A

IT, QA, & Business Managers and Professionals who need to:

Manage or participate on computer system projects requiring validation
Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
Understand the process of computer system validation
Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
Understand the FDA and international regulatory landscape around CSV

This seminar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
Examples of who will benefit from this seminar include:

Information Technology Analysts
Information Technology Developers and Testers
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
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

This seminar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Course Director: CAROLYN TROIANO

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.

CSV vs CSA - Waterfall vs. Agile Methodology, Documentation and Implementation

About The Course:

Course Director: CAROLYN TROIANO