Practical Computerized and Automated System Validation

Two Days Training Session

By discussing Patient Risk-based Approach, this Training session focuses on developing and implementing regulated digital and computerized systems with an appropriate level of documented evidence to satisfy Regulatory expectations. The hands-on training targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach based on patient safety. The core elements of a satisfactory digital and computerized validation program will be emphasized.

Topics to be discussed include:

  • The regulatory expectations for computer validation
  • 21 CFR part 11; GUI-0050 and EU GMP Annex 11 and there’s implications for common regulations
  • The implications of GAMP 5 on computer validation
  • Discover a GDPR Compliant Approach for Software Services
  • Relevant FDA warning letters
  • Science Based Quality Risk Management
  • Data Integrity Design and Validation Consideration
  • Life Cycle Phases of Computerized Systems
  • The tasks and deliverables expected for computer validation
  • Why validation processes vary so much
  • Strategies for practical, yet defensible computer validation
  • Sops required for system operation and maintenance
  • An active discussion of part 11 examples and audience questions
  • Move from Paper to Electronic Systems
  • Manage Changes in Computer Systems
  • Conduct Risk-based Revalidations and Periodic Reviews

Learning Objectives

  • Understand of how to comply with key FDA, Health Canada and international CSV regulations and guidance, such as 21 CFR Part 11, GUI-0050 and EU GMP Annex 11
  • Learn the fundamentals of computer system hardware and software
  • Learn the skills to plan, implement and document effectively validation activities for computerized systems
  • and to assess them with respect to their GxP compliance
  • Know the purpose of each validation deliverable and gaining hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
  • Apply the principals and practices of computer system validation to various pharmaceutical computer system projects including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
  • Develop a system description and user requirement suitable for manufacturing safe medicines.
  • Comprehension of risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
  • Learn how to manage electronic data using GAMP®5 and 21 CFR Part 11, GUI-0050 and EU GMP Annex 11
  • Awareness of best-practices and stakeholder expectations for computer system validation and software quality assurance (SQA) programs

Who should attend?

This Training session is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The Training session is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems.

General Information

– Training material and practical examples will be distributed
– A Certificate of Training completion will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant

Introduction to USFDA 21 CFR Part 11

The 21 cfr part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.

Objectives

The objective of this free webinar is to share the basic principles of the 21 cfr part 11 Requirements. This session will provide you with information and will allow you to understand the ins and outs of this regulation.

Contents

  • The History of 21 CFR Part 11: When and Why was This Regulation Adopted?
  • What documents and signatures does Part 11 apply to? And what documents and signatures are outside the scope of the regulations?
  • Part 11 Technical, procedural and documentary requirements for electronic records, electronic signatures and open systems
  • FDA Guide to Part 11 Compliance
  • Step-by-step methodology for executing your Part 11 compliance project
  • Actions and Trends in FDA’s Enforcement of 21 CFR Part 11
  • Examples of Recent FDA Warning Letters for Electronic Records Violation
  • Thoughts on the Future of Part 11

Attendees

Anyone interested in USFDA 21 CFR Part 11

General Information

– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

Digital & Computerized System Validation

The V-model has become a standard worldwide methodology for the validation of digital and computerized systems. Regulatory requirements, as well as industry guidelines, like GAMP®5, are orientated towards this model. But in Digital Transformation world, the validation execution should follow the principles of Quality and Data Integrity by Design which should call for Validation by design (Validation 4.0).

Objectives

As a specialist for the validation of digital and computerized systems, this Live Online Training will provide you with:

  • Suggestions on how current regulatory guidance on cloud computing and computerized systems relating to data integrity, critical thinking and Computer Software Assurance can be put into practice
  • Approaches and principles of Validation 4.0 and Validation by design
  • Real-life examples of how validation effort can be scaled according to risk-based approaches
  • Cloud Infrastructure risk evaluation and qualification
  • Answers to specific questions, e.g. on source code review or on creating specification documents
  • The opportunity to bring questions from your own practice up for discussion

Contents

  • Current Challenges and Evolution for CSV Activities
  • Health Canada GUI-0050, GAMP®5, 21 CFR Part 11, EU Annex 11, Data Integrity
  • Roles, Responsibilities and Governance
  • IT System Validation Lifecycle implementation and management
  • Scalability of Validation Activities
  • System, Process & Requirements Risk Assessment
  • Writing Requirements Documents
  • Requirements: The Good, the Bad and the Ugly
  • Effective Content of a CSV SOP
  • Data Integrity and Record Management
  • Design Review – How to Apply Critical Thinking
  • Bringing Legacy Systems into Compliance

Attendees

The Master Class is directed at employees from:

  • IT
  • Production
  • Engineering
  • Quality Assurance
  • Quality Control

Participants should already have gained experience in the validation of computerized systems, and preferably will have also attended a basic CSV Course.

General Information

– Training material and practical examples will be distributed
– An attestation of course completion will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

Risk-based Continued Process Verification

Objectives:

The third phase of the process validation life cycle, continued process verification, is the ongoing assurance that the routine process remains in a state of control. When product knowledge and process understanding are gained through Stage 3, the expectation is to use that information immediately for continuous improvement actions. This stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”.

This session addresses the concepts, methods and tools (e.g. Lean Six Sigma and QRM) used in ongoing/continued process verification (CPV).

Content

This Validation Masterclass will provide some answers to the following questions:

  • FDA and EMA Guidance regarding Process Validation and Continued Process Verification
  • How to Build Blocks of QbD – Design Space, Process Control and Assessing Risk
  • How to define Process Control Strategy – Stability and Capability Methods
  • How to apply Quality Risk Management to Continued Process Verification
  • How to implement Continued/Ongoing Process Verification in the routine production – beginning from the definition of the control strategy to the Product Quality Review /Annual Product Review?
  • What is state of the art regarding systems for detecting unplanned departures from the process?
  • How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
  • How to deploy Lean Six Sigma tools to monitor and control Ongoing Manufacturing Process
  • What are the differences between Continued Process Verification (FDA), Continuous Process Verification (ICH Q8) and Ongoing Process Verification (EU) ?
  • Are there parallels regarding Medical Devices?
  • What statistic parameters could help?
  • Is a statistician necessary?
  • How is OPV/CPV linked to PQR/APR?
  • What are the expectations of the Regulatory Bodies (FDA, EU, MHRA, TGA, Health Canada, etc) ?

Attendees

  • Manufacturing Managers and personnel
  • Department managers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Process and Manufacturing Engineers
  • Quality Assurance Personnel
  • Anyone with a desire to learn the fundamentals of methodical performance improvement

General Information

– Participants will receive a copy of the presentation(s), relevant notes and Master Class materials.
– A certificate of completion will be issued to participants.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant

Introduction to EU GMP Annex 11

The EU GMP Annex 11 applies to all forms of computerized systems used as part of a GMP regulated activities. A computerized system is a set of software and hardware components which together fulfill certain functionalities. The application and system must be qualified and/or validated.

Objectives

EU Annex 11 is not a legal requirement; it is a guideline in the context of EU Good Manufacturing Practices (GMP). However, Annex 11 is mandatory at each EU national level as Member States must endorse the EU GMP Directive as part of national health legislation.

During this free webinar, you will learn key fundamental EU terminology to understand Annex 11, its application as well as its history.

We will review the detailed requirements of Annex 11 and explore approaches and processes to ensure compliance

Content

  • History and background of Annex 11
  • Scope of Annex 11 – which companies must comply
  • Annex 11 Compliance Requirements and Approaches
  • Comparison of Annex 11 and Part 11
  • Guidance documents and related standards

Attendees

Anyone interested in EU GMP Annex 11

General Information

– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant