CSV VS CSA - WATERFALL VS. AGILE METHODOLOGY

CSV VS CSA - WATERFALL VS. AGILE METHODOLOGY, DOCUMENTATION AND IMPLEMENTATION

Dates: JULY 28 - 29, 2022 Time (Eastern Time US): 10 AM to 2 PM Time (Central Europe): 4 PM to 8 PM

Duration: 2 DAYSCourse Director: CAROLYN TROIANO

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 Should You 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

“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

WHO SHOULD ATTEND

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.

AGENDA

10:00 AM - 02:00 PM

Day 1

• 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

10:00 AM - 02:00 PM

Day 2

• 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