• 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

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

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

• 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

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

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

• 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

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

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.

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

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 – 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

• 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

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

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

• 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

• 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

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

• 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

• 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

• 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

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

• 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

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

• 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

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

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.

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

• 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

• 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

• 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