Workshop Details

Dates

September 26, 2024

Time

1:30 pm – 4:30 pm

Cost

CAD $395 + HST

Location

Online

Deadline

September 19, 2024

Workshop Overview

Computer System Validation (CSV), or Software Validation, is a critical regulatory requirement mandated by Health Canada, the FDA, and the European Union. This regulation ensures that all computerized systems or automated data processing systems used in the healthcare industry (including Pharma, Medical Devices, Logistics, and Warehousing) are validated for their intended use according to established pre-defined protocols before production use.

This workshop provides a foundational understanding of Software Validation and its regulations throughout the life cycle of any computerized system. This workshop equips participants with the essential knowledge required for day-to-day operations in any regulated healthcare industry.

Participants will explore the regulations and standards behind CSV, gain insights into recommendations and best practices, and understand the role of GAMP®5 (GAMP5). Additionally, the workshop will cover the competencies required for a validation team and offer practical comprehension and application of CSV techniques to ensure efficient, effective, and inspection-ready validation initiatives.

Who Should Attend​

This workshop is designed for professionals involved in the healthcare industry, including Pharma, Medical Devices, Logistics, and Warehousing sectors, who are responsible for the validation of computerized systems. It is particularly beneficial for quality assurance professionals, regulatory affairs specialists, IT personnel, validation engineers, and compliance officers. Additionally, individuals involved in developing, implementing, or overseeing validation protocols and procedures will find this training invaluable for ensuring compliance with regulatory requirements.

Workshop Outline

This workshop covers the following topics:

  • Overview of Validation Principles
  • Introduction to GAMP 5 and System Categorization
  • Phases of the System Development Life Cycle (SDLC)
  • Detailed Explanation of the V-Model Approach
  • Key CSV Project Deliverables: Requirements Documents, Validation Plans, Validation Protocols (IQ, OQ, PQ), Test Plans, and Test Reports
  • Guidance on 21 CFR Part 11 Compliance
  • Understanding the FDA and International Regulatory Landscape for CSV

Learning Outcomes

Understanding Regulatory Requirements:

Gain a comprehensive understanding of current computer system validation regulatory requirements and their implications for the healthcare industry.

Mastering the System Development Life Cycle

Develop a detailed understanding of the life cycle phases in system development, including the application of the V-model approach.

Creating and Managing Validation Deliverables

Learn how to create, review, and approve essential validation deliverables such as requirements documents, validation plans, protocols (IQ, OQ, PQ), test plans, and test reports

Maintaining Validated Systems and Audit Readiness

Understand how to maintain systems in a validated state and gain insights into audit requirements related to computer system validation to ensure compliance and readiness.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Computer System Validation (CSV) – Introduction to General Principles

September 26, 2024

Other Workshops Available

Krishnachaitanya Pabbaraju

AAPS

instructor

CSV professional with more than 10 years of experience in validation of Computer Systems, Quality Systems in pharmaceutical, Medical Devices, Biotech, and Healthcare Logistics industries with wide experience in GXP, 21 CFR part 11, Annex -11, GAMP 5 compliance (Validation and Quality).

Primarily worked in Validation activities related to ERP systems, Quality Management Systems, Document Management, Lab systems, Lab Information Management (LIMS), TrackWise, Learning Management (LMS), Validation Life Cycle Management (VLMS) systems and Supply chain Validation.

Extensive experience in Global IT Quality systems creation, rollout and management including Global IT Policy, SOPs, and Procedures.

Currently leading a healthcare Logistics company with implementation of technological innovations to improve the quality and compliance.