Sheraton Mission Valley San Diego, 1433 Camino del Rio S, San Diego, CA 92108
AGENDA
11:55 - 12:00 PM
Start of Day 1
12:00 - 1:00PM PST
Registration - Coffee & Tea
1:00 - 1:15 PM PST
Chairperson's Opening Remarks
1:15 - 2:15 PM PST
Panel: Agency Updates, Compliance Trends, Process Innovation, Digitalization, and the Future of Validation
Moderator: LeAnna Pearson, Associate Director for Quality Compliance & Regulatory, CAI Panelists: Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics Roque Redondo, Sr. Technical Consultant, Mentor Technical Group Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA Daniel Walter, Policy Analyst, CDRH, U.S. FDA
2:15 - 3:00pm PST
Modernize Risk Assessments by Using Critical Thinking
Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group
- Demonstration of risk assessments concepts
- Demonstration of risk assessments tools and strategies
- Pivoting away from traditional risk assessments and encompassing critical thinking
- Pivoting from CSV to CSA with critical thinking/risk assessment in mind
- Real world highlights of CSA implementation case study with critical thinking and modernized risk assessmentTakeaway Tools
- FDA CSA draft guidance (Sep 2022)
- Article link on critical thinking with modernized risk assessment and QdB
- Case study example of with critical thinking and modernized risk assessment
3:00 - 3:15 PM PST
Networking Refreshment Break and Exhibit Showroom
3:15 - 3:45
select Between Knowledge Exchange Sessions
3:15 - 3:45
AI Readiness: Rethink Validation and GxP Operations
David Blewitt, VP of Cloud Compliance, USDM Life Sciences
3:15 - 3:45
IQ/OQ/PQ - Master Risk-based Equipment Qualification
Neal Schmidt, MS, PMP, Senior Manager of Validation, Resilience
3:50 - 4:20
Harness the Power and Understand the Benefits of Using AI in Validation Now
Rosalind Beasley, CEO, Main and Mission, Inc.
- Understand the core principles of AI and its role in validation
- Learn how to overcome common validation challenges using AI driven solutions
- Gain insights into enhancing data integrity and compliance through AI algorithms
- Discover the types of data needed to integrate AI into existing validation workflows
- Evaluate the risks associated with using AI in the validation process and how to mitigate
- Stay ahead of the curve by understanding future AI trends
Takeaway Tools:
- Checklist to ensure your AI in CSV meets regulatory requirements
- White paper discussing the use of AI in CSV, including benefits, challenges, and solutions
Takeaway Tools:
3:50 - 4:20
Conduct Risk-based Revalations and Periodic Reviews of Validated Systems
Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics
4:30 - 5:00
Validation Knowledge Management - Leverage Technology for ContinuousImprovement
Chinmoy Roy, Senior Industry Consultant, ValGenesis
a. Advantages of using a paperless approach
b. How to leverage a paperless approach for validation across the board
c. The efficiency and time it saves for companies
4:30 - 5:00 PM PST
Best in Class Documentation - SOPs, Masterplans, and Checklists
Jamie Virnig, Validation Engineer, Exact Sciences
- Define what makes documents great (and what makes them not-so-great)
- Learn how to generate documents that will stand on their own
- Identify key features needed to create templates that can be used across your organization
- Understand the different document types and when to use them
- Learn how to create a document hierarchy that works for your organization
Takeaway Tools:
- Framework for generating great documents
- Examples of document templates
- Sample document hierarchies
Takeaway Tools:
7:00 AM PST
Start of Day 2
7:00 - 8:00 AM PST
Exhibitor Showroom Opens and Lite Breakfast
8:10 - 8:50am PST
Change Control: Using Risk when Making Changes to Validated Systems
Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas
- Understanding your unique risks
- Why risk management is necessary
- Risk mitigation versus risk management
- Using experience to navigate risk evaluation and validation
- Not all risk is bad risk: using risk for better change management
Takeaway Tools:
- Outline for an effective risk management procedure
- Tips for approaching change control from a risk managed mindset
Takeaway Tools:
8:10 - 8:50am PST
Annex 1 and the Impact on Validation
David Vincent, Chief Scientific Officer, VTI Life Sciences
Cleanroom Qualification
- Qualification of cleanrooms according to new annex 1 requirements:
- Contamination control strategy
- Full review of environmental monitoring program to include new requirements
- Validation of exposure time for settle plates – recovery studies and desiccation degree
- Determination of recovery of sampling methods and neutralization efficacy
- Full outsourcing of environmental monitoring program (sampling, testing and trend analysis)
- Trend analysis of EM results and changes of microbial flora cleaning & disinfection validation
Validation of cleaning and disinfection procedures for movement of materials:
- Cleaning validation of primary packaging (bioburden, particle matter and endotoxins)
- Cleaning validation of RABS and isolators
- Validation of cleaning and disinfection of cleanrooms
- Disinfectant validation studies and quality controls
- Disinfectant effectiveness under in use conditions, with and without mechanical
- Qualification of the pure steam generator for chemical and endotoxins levels
- Review of water systems monitoring program
- Sampling and testing according to current pharmacopoeias
- Identification of microbial isolates and trend analysisAseptic Processing Validation:
- Validation of holding times for each step of aseptic preparation and processing (cleaning, decontamination, sterilization)
- Validation of the microbiological method used for APS / media fills : recovery of microorganisms from simulation materials, sensitivity of the method, validation of incubation conditions and inoculation of positive controls ( (including local isolates)
- Incubation and inspection of APS media fills
Knowledge Exchange:
Manufacturers are now required to have a clear rationale for preventing contamination of finished products by microorganisms, particulate or pyrogens, by designing, validating and monitoring a comprehensive, facility wide strategy
8:10 - 8:50am PST
Data Tracking and Monitoring the Outputs of Risk Assessments: From Risk to Evidence on a Path Towards Knowledge – A Structured Approach
Rui Almeida, Director – Consultancy Services, Valgenesis
Provide the audience with a structured approach where risk-based decisions and data-driven decisions will enable companies to drive horizontal and vertical integrations of product knowledge within their portfolios:
- Introduction on evidence & risk over life-cycle
- Regulatory overview and KASA alignment
- Structured approach for risk and data-driven decision-making (3 steps)
- Final remarks
8:50 - 10:00
Refreshment Break, Speed Training & Networking
10:00 - 11:30
Select Between Knowledge Exchange Sessions
10:00 - 11:30
Case Study: Using Risk Across the Process Validation Lifecycle - The How, When, Where, and Why Uncovered
Connie Hetzler, Global Validation Head, Alcon
- The how is anchored in the beginning of the product life cycle
- Examples of risk assessment in the product design
- How these choices impact manufacturing and process validation
- The when is critical and often comes too late
- Risk principles are applied during the use of risk tools
- Example of how and when to use risk tools
- Cross-functional perspective are essential to risk assessment
- Process validation is at the intersection of multiple functions
- The why has more than one answer
- Patient
- Business
- Compliance
- Examples of risk assessment in the product design
- How these choices impact manufacturing and process validation
- Risk principles are applied during the use of risk tools
- Example of how and when to use risk tools
- Cross-functional perspective are essential to risk assessment
- Process validation is at the intersection of multiple functions
- Patient
- Business
- Compliance
10:00 - 11:30
Mastering Critical Elements in Cleaning Validation
Cindy Duhigg, Global Process Validation Steward, Alcon
Attendee Benefits
- What is QbD, and why should you care?
- How to recognize a “validatable” cleaning process – CQAs, CPPs, design/control/operating spaces
- The dirty truth about cleaning validation limits
- Determining what qualifies as a “toxicological evaluation”
- Making sense of the alphabet soup
Takeaway Tools: - Case study: risk management around “new” regulatory requirements
10:00 - 11:30
Validation for Digital Threads
Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA (Invited) Daniel Walter, Policy Analyst, CDRH, U.S. FDA (Invited) Jason Spiegler, SVP Strategy & Customer Experience, Compliance Group (Invited)
Part 1 – DI Maturity: What is it?
- Understand the critical elements of a data integrity program: assessing computerized systems, building procedural and technical controls, improving behaviors
- Understand why building a data integrity maturity model is critical to your organization
- Learn how to assess your organization’s data maturity
- Identify attributes to improving technical, procedural, and behavioral data integrity
- Learn what a data governance maturity model is and which model your organization should use
- Part 2 – DI Maturity:The How
- Learn how to identify data vulnerabilities
- Understand the importance of interconnectivity and Pharma 4.0 in maturing data integrity in your organization
- Review a failed data integrity program case study: what went wrong?
- Review a successful data integrity program case study: what caused its success?
- Identify real technical solutions to computerized systems that will enhance data integrity maturity
- Knowledge Exchange:
Attendees take part in a round-the-room conversation comparing real life DI challenges in today’s industryTakeaway Tools - Examples of real-life DI challenges in programs and what we can do to improve
11:40 - 12:20pm PST
Select Between Knowledge Exchange Sessions
11:40 - 12:20pm PST
Assay Qualification, Validation, Transfer: Are we living in a “Land of Confusion”?
Douglas Brown, Senior Scientist and Manager, Charles River Laboratories
- Understanding the three (3) steps to validating any system: plan, execute, evaluate
- Understanding the differences between manual, semi-automated and fully automated VIS and the differences required to validate each
- Learning how to utilize common risk-based principles for efficiency gains in your validation effort
- Understanding the limitation of automated inspection
- Improving future state of VIS validation by utilizing AI and machine learning
Takeaway Tools:
- Example of visual inspection validation plan
Takeaway Tools:
11:40 - 12:20pm PST
Spray Coverage, CleaningValidation, andRoutine Monitoring Equipment Grouping
Alexandra Bezilla, Project Manager, Technical Specialist, Sherpa Pharma
Session Content
- Summarize the general process flow for a GMP cleaning validation event for a specific scenario/case study: a clinical advanced therapeutics manufacturing cleanroom
- Summarize and evaluate the criteria for equipment grouping in preparation for a cleaning validation:
- Grouping considerations for spray coverage testing (challenges, regulatory expectations, compliance insights)
- Grouping considerations for routine monitoring equipment (simplifying the process by designing equipment families, and identifying unique systems)
- Impact that optimized grouping has on a successful validation
- Discuss impact that spray coverage has on cleaning validation data
- Regulatory guidance, testing approaches, justification challenges
Takeaway Tools:
- Cleaning validation process workflow & visuals
- Equipment grouping guidelines
11:40 - 12:20pm PST
Application Upgrades: How to Zero in on What Matters
Joe Ault, Senior Product Marketing Manager, Software, Thermo Fisher Scientific
12:20- 1:20pm PST
Lunch and Learn
1:20 - 2:00
Select Between Knowledge Exchange Sessions
1:20 - 2:00
Navigating Comments in Paperless Validation
Washington Nguyen, Director of Validation Services – Southeast, Ellab
1:20 - 2:00
Continued Process Verification - Mastering Process Validation Stage 3
Douglas Brown, Senior Scientist and Manager, Charles River Laboratories
Once a validation is completed, a new phase in the lifecycle process is entered and the product owner must continue to ensure what has been established (validated) continues to perform as it is intended. During this session, a understanding and documenting process for this stage will be outlined, terms and concepts will be discussed, and an overview of how one might evaluate risks and potentially implement necessary changes to the validated testing system.
1:20 - 2:00
Auditing Audit Trails- Your Plan for Success
Joscelyn Bowersock, Senior Director, Quality Assurance and Regulatory, Precision for Medicine
Part 1 – Regulatory Review
• Regulation requirements (US and EU)
• Common inspection citations
Part 2 – Defining Your System
• Defining ALCOA+ in electronic systems
• Questions to ask to meet regulatory requirements
Part 3 – Risk Based Approach
• Reading the regulations in your favor
• How often should I vs how often do I?
• Is more really better?
Knowledge Exchange:
Attendees will participate in case studies to discuss best practices and how to avoid pitfalls
Takeaway Tools:
• Risk assessment workflow model
• Audit trail checklist
1:50 - 2:30pm PST
Select Between Knowledge Exchange Sessions
1:50 - 2:30pm PST
Develop an Impressive Validation Master Plan (VMP) for Regulators
Olivia Calder, Process Engineer, Kneat
Empower your validation planning in 2024 with a tech edge that will set your team up with a roadmap for success. This session will guide you through the intricacies of creating a robust validation master plan (VMP) and validation plan (VP) and show you how our digital validation solution, Kneat Gx, amplifies the efficiency and effectiveness of your validation plans.
1:50 - 2:30pm PST
Critical Utility Qualification - HVAC, Water, and Process Gasses
David Vincent, Chief Scientific Officer, VTI Life Sciences
1 – General Utility Qualification Approach:
• Guideline status
• Impact assessment/boundaries
• Qualification – IQ/OQ/PQ
• Monitoring – frequency + requirements
• Requalification
2 – Qualification/Parameters Per Utility Type:
• Clean steam
• Heating, ventilation and air conditioning
• Process gasses
• Water systems
• Qualitative/quantitative approach
• Microbiological/chemical methods
• Sampling techniques/equipment
• Analytical methods
Knowledge Exchange:
Project examples, root case and remediation encountered during utility qualification projects are discussed
Takeaway Tools:
• Impact assessment tool
1:50 - 2:30pm PST
Behavioral Change - Secrets to Implementing a Successful Transition from CSV to CSA
Margaret Hindley PhD, CQA, CQE, Director CSA/IT, Taiho Oncology
- Learn how to get organized, find a champion, and get started
- Learn how to assess your current validation program
- Understand how to pick the right people for the project (quality, IT, etc.)
- Understand organizational change management principles
- Understand the importance of the training component to the project
- Learn how to assess a successful project
Takeaway Tools:
- Example high level project plan
Takeaway Tools:
2:30 - 3:00pm PST
Exhibitor Showroom and Refreshment Break
3:00 - 3:40pm PST
Select Between Knowledge Exchange Sessions
3:00 - 3:40pm PST
Accelerate Process Validation with Data-Based Quality by Design
Alexandra Bezilla, Project Manager, Technical Specialist, Sherpa Pharma
Session Content
- Case study approach, using a standard APV/media fill event as the scenario tool
o Define the data (aka risk) based QbD philosophy - Summarize the general APV workflow, highlighting the QbD advancements that digital & cloud-based systems provide
- Emphasize and demonstrate the time savings as compared to a non-optimized approach, and explain that the future trends point in this direction
Takeaway Tools - Example ROI report for digital data collection and management
- APV process workflow & visuals
3:00 - 3:40pm PST
Integrated Compliance
Mark Lawson, Executive Director of Quality and Compliance, Compliance Group Lakshmi Chitrapu, Manager, Quality and Compliance, Compliance Group
3:00 - 3:40pm PST
Build a Data Integrity Maturity Model for Compliance
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
Cordero,Validation Manager,Bausch&Lomb
Part 1 – DI Maturity: What is it?
- Understand the critical elements of a data integrity program: assessing computerized systems, building procedural and technical controls, improving behaviors
- Understand why building a data integrity maturity model is critical to your organization
- Learn how to assess your organization’s data maturity
- Identify attributes to improving technical, procedural, and behavioral data integrity
- Learn what a data governance maturity model is and which model your organization should use
Part 2 – DI Maturity: The How - Learn how to identify data vulnerabilities
- Understand the importance of interconnectivity and Pharma 4.0 in maturing data integrity in your organization
- Review a failed data integrity program case study: what went wrong?
- Review a successful data integrity program case study: what caused its success?
- Identify real technical solutions to computerized systems that will enhance data integrity maturity
Knowledge Exchange
Attendees take part in a round-the-room conversation comparing real life DI challenges in today’s industry
Takeaway Tools: - Examples of real-life DI challenges in programs and what we can do to improve
3:50 - 4:30pm PST
Select Between Knowledge Exchange Sessions
3:50 - 4:30pm PST
Validation Training -Implementation and Measures of Success
Madhavi Ganesan, Life Sciences Solution Director, KPMG
3:50 - 4:30pm PST
Temperature Mapping Qualification in Controlled Environments
Neal Schmidt MS PMP, Senior Manager of Validation, Resilience
3:50 - 4:30pm PST
The Intersection of GAMP® 5 & CSA - Create a Checklist for Success
Emily Dickinson MS ASQ CQA, Associate Director of Quality Assurance, Linical Americas
- Considering GAMP® 5 versus CSA
- Understanding your systems unique attributes
- Risk management throughout the system lifecycle
- Creating your CSA toolkit
- Continuous improvement: level up your checklist for ultimate success
- Takeaway Tools:
- Phase-flexible checklist for computer software assurance
4:30 PM PST
End of Day 2
7:30 - 8:30 PDT
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 10:00 PDT
Select Between Knowledge Exchange Sessions
8:30 - 10:00 PDT
Process Validation Statistics for Non-statisticians
Cindy Duhigg, Global Process Validation Steward, Alcon
8:30 - 10:00 PDT
Conduct an Environmental Monitoring Performance Qualification
Matthew Galley, Director, Commissioning and Qualification, VEQTOR
• Utilization of risk-based and science-based principles for ensuring an efficiency EM qualification process
o How to conduct a thorough EM risk assessment to ensure it is a sound microbial control strategy (use of risk-based principles)
• Creation of an EM PQ plan that utilizes this evaluation and assessment to provide sufficient sampling locations and methods for sampling
• Utilization of ISO 13408-1 for contamination probability
• Helpful tips and tricks to make tedious multi-day static and dynamic EM testing smooth
Takeway Tools
1. EM risk assessment template and tools
2. EMP PQ plan templates
3. Examples of pre-requisites prior to commencing testing
8:30 - 10:00 PDT
CSA Essentials for a Connected Enterprise Solution
Madhavi Ganesan, Life Sciences Solution Director, KPMG
Having compliant, reliable and available data is vital for life sciences businesses to stay competitive in today’s global market. However, with the evolving technology landscape and increasing complexities in the IT environment, it can be challenging to validate an enterprise connected IT solution that meets the unique business needs of your organization.
In this session, we will have a fireside discussion to not just describe the key elements that make up a successful enterprise connected IT solution but also provide insights on how to strengthen and validate IT solutions, including key data integrity and security compliance requirements.
Attendees will learn about:
• Best practices for building successful enterprise connected IT solutions
• CSA strategies for strengthening and validating IT solutions to meet the unique needs of their organization
• Data Integrity requirements to ensure secure and reliable data
• Optimizing cost-effectiveness while maintaining quality
10:00 - 10:30 PST
Refreshment Break, Speed Training & Networking
10:30 - 11:10 PST
Select Between Knowledge Exchange Sessions
10:30 - 11:10 PST
Validation of Single Use Systems (SUSs)
Yuk Chun Chiu, CMO, Wheeler Bio
• Industry trends on single use technologies
• Applying a risk-based approach for SUSs CQV
• Understand the importance of leveraging vendor CQV efforts
• Change managements for SUSs
10:30 - 11:10 PST
Risk-Based Critical Process Parameters and Quality Attributes (CPP and CQA)
Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics
• Learn how to identify the risk impact areas of CPP’s and CQA’s
• Learn the inputs to CPP’s and CQA’s risk-based assessments
• Learn how to assess and identify CPP’s and CQA’s
• Learn how to develop tools to assess the risk impact and criticality of process parameters and quality attributes
• Learn how to implement a risk-based approach to the validation of different process parameters and quality attributes
Takeaway Tools:
• Example template for risk based CPP’s and CQA’s assessments
10:30 - 11:10 PST
Transitioning A Current CSV Program to Align with CSA: A Case Study
Margaret Hindley PhD, CQA, CQE, Director CSA/IT, Taiho Oncology
• Learn where to get started in your new program
• Learn how to pick and choose what keep from your current validation program
• Understand the what & why of the newly added elements
• Understand that the right people make the project (quality, IT, etc.)
• Understand how to prepare the organization for the change that is coming
• Understand the importance of the training component to the project (both pre and post)
Takeaway Tools:
• Example initial risk assessment
• Example risk table
11:20 - 12:00 PDT
Select Between Knowledge Exchange Sessions
11:20 - 12:00 PDT
Using Statistics as a Validation Risk Tool
Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson
In this talk we will discuss:
I. How statistical tools allow us to identify and quantify risk in validation and regular production
II. Overview and examples of some of the most useful statistical tools in validation
a. Process capability analysis
b. Tolerance intervals
c. Acceptance sampling for attributes
d. Hypothesis testing and ANOVA
11:20 - 12:00 PDT
Implement a Data Infrastructure for Advanced Analytics
Yuk Chun Chiu, CMO, Wheeler Bio
11:20 - 12:00 PDT
Validation of AI/ML and Other Superintelligent Platforms
Rosalind Beasley, CEO, Main and Mission, Inc.
• Learn the key principles and requirements that underpin AI/ML validation
• Navigate the complexities of AI/ML data integrity and regulatory compliance
• Understand strategies to effectively manage and mitigate AI/ML risks
• Gain insight into the latest AI/ML validation methodologies and guidance
• Discover approaches to maintain AI/ML validated state
• Stay ahead of the curve by understanding future AI trends
Takeaway Tools:
• Essential steps in the validation process for AI/ML
• Key AI considerations in the master validation plan
12:00 - 1:00 PST
Networking Luncheon -Ask the FDA-Bring Your Compliance Questions
Francisco (Cisco) Vicenty, Case for QualityProgram Manager, U.S. FDA(Invited) Daniel Walter,PolicyAnalyst, CDRH, U.S. FDA( Invited)
1:00 - 1:40 PST
Select Between Knowledge Exchange Sessions
1:00 - 1:40 PST
Qualifying a Facility from the Ground Up - A Map for CQV
David Vincent, Chief Scientific Officer, VTI Life Sciences
1. Implement Risk Management in Facility Design
• Discuss facility design concepts related to current good manufacturing practices (cGMPs)
• Explain the roles and responsibilities of project team members in defining facility
needs and scope
• Cite engineering design principles related to drug product manufacturing
• Identify pharmaceutical and biotechnology process attributes that impact facility design
• Locate current industry guidance documents. that impact facility design
• Define the facility and equipment lifecycle definitions
• Discuss project economics and its impact on facility design
• Describe current industry trends impacting facility design and construction
2. Construction Management and Risk Management
• Key risk method and tools
• Industry trends and regulatory review
• GMPs and applicable guidance
• Facility issues and design considerations
• GMP utility systems design
• Mechanical/HVAC design
• Construction qualification and commissioning
• Leveraging commissioning to support qualification phase
• Engineering change control
Knowledge Exchange:
Understanding the importance of construction qualification for maintain GEP throughout the life cycle of a facility
1:00 - 1:40 PST
Are You Inspection Ready? Conduct a Gap Analysis of Your Validation Program
Connie Hetzler, Global Validation Head, Alcon
• Levels of requirements in preparing for an audit
o Overall document requirements
o Process validation requirements
• Organizational structure and expectations
o Functional accountabilities
o Training requirements
• Related areas and coordination for an audit
o CAPAs/non-conformances
o Change management
o Customer complaints
1:00 - 1:40 PST
Creating an Effective Supplier Quality Agreement
Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine
Part 1 – Regulatory Review
• Regulation requirements (US and EU)
• Common inspection citations
Part 2 – Defining Your System
• What should it cover?
• Which agreement should be in place?
Part 3 – Managing Changes and Disputes
• Defining disputes and resolutions
• Defining categories for change and change control
• When to use a “no change clause”
Knowledge Exchange:
Attendees will participate in case studies to discuss best practices and how to avoid pitfalls
Takeaway Tools:
• Supplier checklists
• Quality management tools for suppliers
1:50 - 2:30 PST
Select Between Knowledge Exchange Sessions
1:50 - 2:30 PST
What “Validation” Means in a Microbiology Laboratory
Anthony Grilli, CEO & Owner, FOCUS Laboratories
Legitimate microbiological test data is built on a foundation of valid methodology conducted in a controlled environment by trained staff using qualified equipment. No different than the analytical lab, but what validation actually means in a world of viable, mutating, sometimes objectionable sometimes benign moving targets, can be a challenge The term validation can be incorrectly applied in microbiological conversations, often method suitability or verification are more accurate. We will start with a review of terminology, highlighting the differences between validation, verification, qualification, and suitability. We then compare true microbiological method validation to its analytical counterpart, showing the parallel components that are quite distinct in execution.
• Learn the vocabulary of validation as applied to a microbiology laboratory.
• See an outline of a standard microbiological test, detailing inputs and process stops that require traceability to a universal standard to achieve a valid end result.
• Know which components of analytical method validation do not precisely match microbiological method validation and why.
• Understand some of the challenges validating an alternative microbiological method against a culture based referee test.
Takeaway Tools
• A glossary of microbiological validation terminology.
• HACCP diagrams of standard microbiology tests, highlighting control points and critical limits.
• Case study of an alternative microbiological method.
1:50 - 2:30 PST
Construct and Analyze Validation Control Charts
Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson
In this talk we will discuss:
I. What is process control vs process capability
II. Various types of control charts, and when to use each
III. How to construct and analyze control charts to determine if the process in validation (and regular production) is in a state of control
IV. How to use average run length (ARL) to evaluate how your charts are performing
V. How to estimate process capability using the results of a control chart
1:50 - 2:30 PST
Conduct a Change Control Impact Assessment
Ivan Soto, Senior Director of QA Validation & Engineering, Serepta Therapeutics
• Learn the elements that define change control criticality based on its impact not the activities
• Learn the inputs to change control validation impact assessments
• Learn how to implement risk-based change control validation impact assessments
• Learn how to develop tools to assess the validation impact and criticality of changes to validated systems and processes
• Learn how to implement a risk-based approach to validate changes to validated systems and processes
Takeaway Tools:
• Example template for risk-based change control impact assessments
2:30 - 3:00 PDT
Exhibitor Showroom and Refreshment Break
3:00 - 3:40 PDT
Select Between Knowledge Exchange Sessions
3:00 - 3:40 PDT
How to Navigate the Data Integrity Maze
Roque Redondo, Sr. Technical Consultant, Mentor Technical Group
3:00 - 3:40 PDT
Transition from Paper Validation to Digital Platforms
Jonathon Thompson, Director of Product Management, Digital Enablement, CAI
3:00 - 3:40 PDT
Analytical Methods Validation for QA and Validation Professionals
Jamie Virnig, Validation Engineer, Exact Sciences
• Define the deliverables for compendial and non-compendial methods
• Learn the difference between method verification and validation
• Understand the prerequisites for method validation
• Identify analytical performance characteristics and how they are used to demonstrate method validity
• Learn how to transfer analytical methods to a different site
Takeaway Tools:
• Examples of analytical method validation documents
• Understanding of how analytical methods are validated
3:50 - 4:30 PDT
Select Between Knowledge Exchange Sessions
3:50 - 4:30 PDT
Using Process Mapping in Data Integrity Governance
Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group
• Demonstration of key issues 483s and warning letter trend in data integrity
• Demonstration of data process mapping assessments concepts
• Demonstration of data process mapping tools and strategies
• Utilization / latest industry trends in data process mapping with data integrity governance
• Integration of data process mapping is a vital component of effective data governance.
• Aligning pharmaceutical practices with regulatory requirements and enhancing data quality and consistency, ultimately benefits product quality and patient well-being
Takeaway Tools:
• FDA standards for data mapping and real world data
• FDA data integrity and compliance with drug CGMP guidance
• Data standards for drug and biological product submissions containing real-world data guidance for industry
3:50 - 4:30 PDT
Learn How to Validate Visual Inspection Systems
Matthew Galley, Director, Commissioning and Qualification, VEQTOR
4:30 PDT
Close of Day Three
VALIDATION UNIVERSITY IS BACK!
Attend in San Diego!
Validation University is a 3-day conference and training program that provides attendees with the latest knowledge and best practices in validation for the life sciences industry. The conference covers a wide range of topics, including Process Validation, Cleaning Validation, Computer System Validation / Computer Software Assurance, Equipment/Facility Qualification, and critical GMP processes that impact validation. Speakers are industry experts who share their insights and experiences on how to implement effective programs and the conference offers networking opportunities and hands-on, interactive training sessions.
Choose From 45+ Tutorials Overflowing With Rich Content And Tangible Takeaways, Including:
Process Validation
- Case Study: Using Risk Across the Process Validation Lifecycle – The How, When, Where, and Why Uncovered
- Process Validation Statistics for Non-statisticians
- Continued Process Verification – Mastering Process Validation Stage 3
- Critical Utility Qualification – HVAC, Water, and Process Gasses
- Accelerate Process Validation with Data-Based Quality by Design
- Process Validation and Successful Tech Transfer
- IQ/OQ/PQ – Master Risk-based Equipment Qualification
Cleaning Validation
- Mastering Critical Elements in Cleaning Validation
- Spray Coverage, Cleaning Validation, and Routine Monitoring Equipment Grouping
- Learn How to Validate Visual Inspection Systems
Computer System Validation & Software Assurance
- Behavioral Change – Secrets to Implementing a Successful Transition from CSV to CSA
- Transitioning A Current CSV Program to Align with CSA: A Case Study
- The Intersection of GAMP® 5 & CSA – Create a Checklist for Success
- Modernize Risk Assessments by Using Critical Thinking
Data Integrity Compliance
- Build a Data Integrity Maturity Model for Compliance
- Implement a Data Infrastructure for Advanced Analytics
- Using Process Mapping in Data Integrity Governance
Quality Metrics & Systems Management
- Data Tracking and Monitoring the Outputs of Risk Assessments: From Risk to Evidence on a Path Towards Knowledge – A Structured Approach
- Best in Class Documentation – SOPs, Masterplans, and Checklists
- Risk-Based Critical Process Parameters and Quality Attributes (CPP and CQA)
Change Control & Risk Management
- Conduct a Change Control Impact Assessment
- Construct and Analyze Validation Control Charts
- Change Control: Using Risk when Making Changes to Validated Systems
Personnel In The Following Environments Should Attend:
- Validation
- QA/QC
- Engineering
- C&Q
- Regulatory and Compliance
- Facility Management
- Manufacturing
- Laboratory
This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.