Instructor :
Carolyn Troiano

Webinar ID:
10674

Bootcamp Objective: Equip you with cost-effective strategies for validating FDA-regulated systems. Learn how to implement robust data integrity measures and navigate data privacy laws with ease. Provide your team with the knowledge to reduce validation costs and enhance compliance efficiency.

For over 30 years, FDA regulations have mandated Computer System Validation (CSV) for systems used in manufacturing, testing, and distribution within pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.

These regulations ensure meticulous planning, implementation, integration, testing, and management of computer systems to maintain accurate and reliable data.

Since 1997, Electronic Records and Electronic Signatures (ER/ES) have been governed by 21 CFR Part 11, which sets the standards for validating and documenting ER/ES capabilities in FDA-regulated environments.

In the early 2000s, recognizing the impossibility of inspecting every computer system, the FDA shifted the responsibility to the industry. Companies must now assess their regulated computer systems based on the risk of failure.

Factors such as following determine the extent of testing needed to ensure data integrity and product safety.

• • System Size
  • Complexity
  • Business Criticality
  • GAMP®5 category
  • Risk Rating

Recent FDA inspections have placed a spotlight on data integrity, emphasizing its critical role in compliance.

All systems that interact with product data must maintain integrity throughout their lifecycle, governed by the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original or True Copy, Accurate, Complete, Consistent, Enduring, and Available.

Participants will explore the significance of 21 CFR Part 11 and how to manage electronic records and signatures effectively.

We’ll offer strategies for ensuring data integrity and Part 11 compliance during system validations.

“ This comprehensive webinar also covers data management across various jurisdictions, including GDPR (EU), HIPAA (US), and CPRA (California), addressing privacy data inventories, DSARs, data breaches, and compliance.“

Best Practices and Strategic Approaches:

• • We’ll discuss best practices and a strategic approach for evaluating computer systems used in FDA-regulated activities, considering the potential risks to data integrity, process and product quality, and consumer/patient safety.
  • System Development Life Cycle (SDLC): Attendees will walk through the SDLC approach to validation, based on risk assessment, and gain insights into the differences between traditional CSV and the newer FDA guidance on Computer Software Assurance (CSA).
  • A focus on critical thinking and a risk-based approach to validation will be emphasized to streamline validation efforts and remove non-value-added work.

Software development methodologies such as the traditional waterfall and more dynamic agile approaches will be covered, highlighting the benefits of each in maintaining cost-effective and compliant systems.

Essential policies, procedures, and supporting documentation necessary for maintaining a validated system state will be detailed, alongside preparations for FDA inspections and vendor audits.

“ Finally, the course will incorporate insights from industry best practices, including GAMP®5, 2nd Edition (2022), and discuss the integration of artificial intelligence (AI) and machine learning (ML) in Software-as-a-Medical Device (SaMD) products, aligning with FDA’s proposed frameworks.“

This in-depth webinar will guide attendees through the entire validation process, from planning to execution, ensuring that your systems are validated, maintained, and retired in accordance with FDA regulations, while also achieving cost reduction.

Join Us Now!

Bootcamp Objective: Equip you with cost-effective strategies for validating FDA-regulated systems. Learn how to implement robust data integrity measures and navigate data privacy laws with ease. Provide your team with the knowledge to reduce validation costs and enhance compliance efficiency.

For over 30 years, FDA regulations have mandated Computer System Validation (CSV) for systems used in manufacturing, testing, and distribution within pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.

These regulations ensure meticulous planning, implementation, integration, testing, and management of computer systems to maintain accurate and reliable data.

Since 1997, Electronic Records and Electronic Signatures (ER/ES) have been governed by 21 CFR Part 11, which sets the standards for validating and documenting ER/ES capabilities in FDA-regulated environments.

In the early 2000s, recognizing the impossibility of inspecting every computer system, the FDA shifted the responsibility to the industry. Companies must now assess their regulated computer systems based on the risk of failure.

Factors such as following determine the extent of testing needed to ensure data integrity and product safety.

• • System Size
  • Complexity
  • Business Criticality
  • GAMP®5 category
  • Risk Rating

Recent FDA inspections have placed a spotlight on data integrity, emphasizing its critical role in compliance.

All systems that interact with product data must maintain integrity throughout their lifecycle, governed by the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original or True Copy, Accurate, Complete, Consistent, Enduring, and Available.

Participants will explore the significance of 21 CFR Part 11 and how to manage electronic records and signatures effectively.

We’ll offer strategies for ensuring data integrity and Part 11 compliance during system validations.

“ This comprehensive webinar also covers data management across various jurisdictions, including GDPR (EU), HIPAA (US), and CPRA (California), addressing privacy data inventories, DSARs, data breaches, and compliance.“

Best Practices and Strategic Approaches:

• • We’ll discuss best practices and a strategic approach for evaluating computer systems used in FDA-regulated activities, considering the potential risks to data integrity, process and product quality, and consumer/patient safety.
  • System Development Life Cycle (SDLC): Attendees will walk through the SDLC approach to validation, based on risk assessment, and gain insights into the differences between traditional CSV and the newer FDA guidance on Computer Software Assurance (CSA).
  • A focus on critical thinking and a risk-based approach to validation will be emphasized to streamline validation efforts and remove non-value-added work.

Software development methodologies such as the traditional waterfall and more dynamic agile approaches will be covered, highlighting the benefits of each in maintaining cost-effective and compliant systems.

Essential policies, procedures, and supporting documentation necessary for maintaining a validated system state will be detailed, alongside preparations for FDA inspections and vendor audits.

“ Finally, the course will incorporate insights from industry best practices, including GAMP®5, 2nd Edition (2022), and discuss the integration of artificial intelligence (AI) and machine learning (ML) in Software-as-a-Medical Device (SaMD) products, aligning with FDA’s proposed frameworks.“

This in-depth webinar will guide attendees through the entire validation process, from planning to execution, ensuring that your systems are validated, maintained, and retired in accordance with FDA regulations, while also achieving cost reduction.

Join Us Now!

• • Are you struggling with the rising costs of system validation while maintaining compliance with FDA regulations?
  • Does navigating the complexities of 21 CFR Part 11 and ensuring data privacy seem daunting?

Validation of any GxP system can be costly if not managed effectively!

“ There’s an ongoing shift towards digitalization and automation in the pharmaceutical and medical device industries. This shift drives a need for understanding how to implement and validate these systems cost-effectively, complying with FDA regulations. This comprehensive training precisely addresses these needs.“

This webinar is designed to equip you with strategic ways to plan, execute, and document validation activities efficiently using the System Development Life Cycle (SDLC) methodology.

Here’s what you will gain:

• • Understand the nuances between Computer System Validation (CSV) and Computer Software Assurance (CSA).
  • Master validation of emerging technologies such as cloud services, Software-as-a-Service (SaaS), and the use of automated testing.
  • Reduce costs of validation and ongoing maintenance of systems in a validated state throughout their lifecycle.

Attendees will learn streamlined methods to address both data integrity and 21 CFR Part 11 compliance, focusing on risk management and critical thinking.

We’ll explore both the traditional waterfall and the agile approaches to software management across its lifecycle.

Key Insights Include:

• Best practices in the industry, including GAMP®5 guidelines, and their application in today’s advanced technological settings.
• Practical strategies to validate systems utilizing cloud and SaaS solutions effectively.
• Innovative ways to minimize costs in the validation process without compromising compliance.
• Insights into Pharma 4.0 and its benefits through the lens of the 12 Theses.

Additionally, we will delve into the FDA’s proposed framework for software containing artificial intelligence (AI) and machine learning (ML), particularly for Software-as-a-Medical Device (SaMD) products.

Join us to transform your approach to validation, ensuring cost-efficiency while maintaining strict compliance with regulatory standards.

Enroll Now!

• • Are you struggling with the rising costs of system validation while maintaining compliance with FDA regulations?
  • Does navigating the complexities of 21 CFR Part 11 and ensuring data privacy seem daunting?

Validation of any GxP system can be costly if not managed effectively!

“ There’s an ongoing shift towards digitalization and automation in the pharmaceutical and medical device industries. This shift drives a need for understanding how to implement and validate these systems cost-effectively, complying with FDA regulations. This comprehensive training precisely addresses these needs.“

This webinar is designed to equip you with strategic ways to plan, execute, and document validation activities efficiently using the System Development Life Cycle (SDLC) methodology.

Here’s what you will gain:

• • Understand the nuances between Computer System Validation (CSV) and Computer Software Assurance (CSA).
  • Master validation of emerging technologies such as cloud services, Software-as-a-Service (SaaS), and the use of automated testing.
  • Reduce costs of validation and ongoing maintenance of systems in a validated state throughout their lifecycle.

Attendees will learn streamlined methods to address both data integrity and 21 CFR Part 11 compliance, focusing on risk management and critical thinking.

We’ll explore both the traditional waterfall and the agile approaches to software management across its lifecycle.

Key Insights Include:

• Best practices in the industry, including GAMP®5 guidelines, and their application in today’s advanced technological settings.
• Practical strategies to validate systems utilizing cloud and SaaS solutions effectively.
• Innovative ways to minimize costs in the validation process without compromising compliance.
• Insights into Pharma 4.0 and its benefits through the lens of the 12 Theses.

Additionally, we will delve into the FDA’s proposed framework for software containing artificial intelligence (AI) and machine learning (ML), particularly for Software-as-a-Medical Device (SaMD) products.

Join us to transform your approach to validation, ensuring cost-efficiency while maintaining strict compliance with regulatory standards.

Enroll Now!

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

DAY 1: 6-Hrs

Overview of current FDA compliance and enforcement: Hour -1

• • FDA tools for engaging stakeholders
  • Recent FDA Concerns and Consequences, and how to prepare and avoid these

Validation Approach

• • Computer System Validation (CSV) (traditional approach)
    • FDA Guidance Documents
    • What FDA Requires
    • FDA Compliance Myths

Validation Planning: Hour -2

• • GAMP®5 Software (GAMP®5, 2nd Edition – July 2022)
    • Best Practices
    • GAMP Software Categorization
    • Changes Since GAMP®5 Original Edition
    • Alignment with Computer Software Assurance (CSA)
  • System and Requirement Risk Assessment

Validation Requirements

• • Functional and System, or Non-Functional Requirements
  • Design and Configuration Management Specifications

Validation Testing: Hour -3

• • Installation Qualification (IQ) Protocol and Summary Report
  • Operational Qualification (OQ) Protocol and Summary Report
  • Performance Qualification (PQ) Protocol and Summary Report

Validation Reporting

• • Validation Summary Report
  • Requirements Traceability Matrix (RTM)
  • GxP System Inventory

Maintaining a System in a Validated State through its entire life cycle: Hour -4

• • Supporting policies, procedures, and practices
  • Business Process Mapping & Reengineering (BPM & BPR)
  • Training – Functional, Technical, Quality, Validation
  • Organizational Change Management (OCM)

Computer Software Assurance (CSA) (draft guidance from FDA in September 2022): Hour -5

• • Comparison of CSV and CSA
  • Risk-Based Approach
  • Critical Thinking
  • Waterfall and agile as optional approaches to SDLC management
  • GAMP®5 “V Model” adapted for agile

Technology: Hour -6

• • Commercial Off-the-Shelf Software (COTS)
  • Cloud Services
  • Software-as-a-Service (SaaS) Solutions
  • Infrastructure-as-a-Service (IaaS) Solutions
  • Platform-as-a-Service (PaaS) Solutions
  • Spreadsheet Validation
  • Single-Sign-On (SSO) Capability

Leveraging a Vendor’s Work Products

• • Automated Testing

Q&A Session with the Presenter: Bring your challenges/questions to enable interactive discussion of items most critical to you.

DAY 2: 6-Hrs

Data Integrity and the ALCOA+ Principles: Hour -7

• • The ALCOA+ Principles
  • Recent Compliance Trends

21 CFR Part 11 Compliance for Electronic Records and Electronic Signatures (ER/ES): Hour -8

• • Technical Features and Controls
  • Procedural Controls
  • Recent Compliance Trends

Data Privacy: Hour -9

• • General Data Protection Regulation (GDPR; EU)
  • Health Information Portability and Accountability Act (HIPAA; US)
  • California Privacy Rights Act (CPRA)
  • Data Inventory
  • Data Subject Access Request (DSAR)
  • Data Breach Requirements

Artificial Intelligence (AI) and Machine Learning (ML): Hour -10

• • Locked Algorithms
  • Adaptive Algorithms

Software-as-a-Medical Device (SaMD)

• • FDA Proposed Framework for Modifications to AI/ML-Based SaMD
  • Total Product Life Cycle (TPLC) Approach
  • International Medical Device Regulators Forum (IMDRF)
  • Good Machine Learning Practice (GMLP)
  • SaMD Pre-Specifications (SPS)
  • Algorithm Change Protocol (ACP)
  • Types of Algorithm Changes and 510k Requirements
    • Performance
    • Inputs
    • Intended Use

Pharma 4.0: Hour -11

• • 12 Theses of Pharma 4.0
  • International Society for Pharmaceutical Engineering (ISPE) Pharma 4.0 Operating Model
  • Digital Transformation and Return-On-Investment (ROI)
  • Data Integrity by Design

Vendor Audit: Hour -12

• • Traditional Vendors
  • Commercial Off-the-Shelf Software (COTS)
  • Cloud Service Providers
  • Software-as-a-Service (SaaS) Vendors
  • Audit Preparation
  • Audit Execution
  • Post-Audit Activities

Preparing for an FDA Computer System and Data Audit

• • Recent FDA Concerns and Consequences, and how to prepare and avoid these
  • Industry Best Practices

Q&A Session with the Presenter: Bring your challenges/questions to enable interactive discussion of items most critical to you.

Take-Home Quiz:

• • Additional slides will include a quiz covering the material will be along with the answers to each question.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

DAY 1: 6-Hrs

Overview of current FDA compliance and enforcement: Hour -1

• • FDA tools for engaging stakeholders
  • Recent FDA Concerns and Consequences, and how to prepare and avoid these

Validation Approach

• • Computer System Validation (CSV) (traditional approach)
    • FDA Guidance Documents
    • What FDA Requires
    • FDA Compliance Myths

Validation Planning: Hour -2

• • GAMP®5 Software (GAMP®5, 2nd Edition – July 2022)
    • Best Practices
    • GAMP Software Categorization
    • Changes Since GAMP®5 Original Edition
    • Alignment with Computer Software Assurance (CSA)
  • System and Requirement Risk Assessment

Validation Requirements

• • Functional and System, or Non-Functional Requirements
  • Design and Configuration Management Specifications

Validation Testing: Hour -3

• • Installation Qualification (IQ) Protocol and Summary Report
  • Operational Qualification (OQ) Protocol and Summary Report
  • Performance Qualification (PQ) Protocol and Summary Report

Validation Reporting

• • Validation Summary Report
  • Requirements Traceability Matrix (RTM)
  • GxP System Inventory

Maintaining a System in a Validated State through its entire life cycle: Hour -4

• • Supporting policies, procedures, and practices
  • Business Process Mapping & Reengineering (BPM & BPR)
  • Training – Functional, Technical, Quality, Validation
  • Organizational Change Management (OCM)

Computer Software Assurance (CSA) (draft guidance from FDA in September 2022): Hour -5

• • Comparison of CSV and CSA
  • Risk-Based Approach
  • Critical Thinking
  • Waterfall and agile as optional approaches to SDLC management
  • GAMP®5 “V Model” adapted for agile

Technology: Hour -6

• • Commercial Off-the-Shelf Software (COTS)
  • Cloud Services
  • Software-as-a-Service (SaaS) Solutions
  • Infrastructure-as-a-Service (IaaS) Solutions
  • Platform-as-a-Service (PaaS) Solutions
  • Spreadsheet Validation
  • Single-Sign-On (SSO) Capability

Leveraging a Vendor’s Work Products

• • Automated Testing

Q&A Session with the Presenter: Bring your challenges/questions to enable interactive discussion of items most critical to you.

DAY 2: 6-Hrs

Data Integrity and the ALCOA+ Principles: Hour -7

• • The ALCOA+ Principles
  • Recent Compliance Trends

21 CFR Part 11 Compliance for Electronic Records and Electronic Signatures (ER/ES): Hour -8

• • Technical Features and Controls
  • Procedural Controls
  • Recent Compliance Trends

Data Privacy: Hour -9

• • General Data Protection Regulation (GDPR; EU)
  • Health Information Portability and Accountability Act (HIPAA; US)
  • California Privacy Rights Act (CPRA)
  • Data Inventory
  • Data Subject Access Request (DSAR)
  • Data Breach Requirements

Artificial Intelligence (AI) and Machine Learning (ML): Hour -10

• • Locked Algorithms
  • Adaptive Algorithms

Software-as-a-Medical Device (SaMD)

• • FDA Proposed Framework for Modifications to AI/ML-Based SaMD
  • Total Product Life Cycle (TPLC) Approach
  • International Medical Device Regulators Forum (IMDRF)
  • Good Machine Learning Practice (GMLP)
  • SaMD Pre-Specifications (SPS)
  • Algorithm Change Protocol (ACP)
  • Types of Algorithm Changes and 510k Requirements
    • Performance
    • Inputs
    • Intended Use

Pharma 4.0: Hour -11

• • 12 Theses of Pharma 4.0
  • International Society for Pharmaceutical Engineering (ISPE) Pharma 4.0 Operating Model
  • Digital Transformation and Return-On-Investment (ROI)
  • Data Integrity by Design

Vendor Audit: Hour -12

• • Traditional Vendors
  • Commercial Off-the-Shelf Software (COTS)
  • Cloud Service Providers
  • Software-as-a-Service (SaaS) Vendors
  • Audit Preparation
  • Audit Execution
  • Post-Audit Activities

Preparing for an FDA Computer System and Data Audit

• • Recent FDA Concerns and Consequences, and how to prepare and avoid these
  • Industry Best Practices

Q&A Session with the Presenter: Bring your challenges/questions to enable interactive discussion of items most critical to you.

Take-Home Quiz:

• • Additional slides will include a quiz covering the material will be along with the answers to each question.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.

Maximize The Learning Experience in A Group Setting!

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries

Maximize The Learning Experience in A Group Setting!

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries