• Review of the Targeted revision of ICH Q9
• Using Risk Management Strategies to determine your Laboratory Health
• Review Implementation Challenges and Solutions
• Continuous Improvement and Risk Management
• Takeaway Tools:
• ICH Q9 Risk Assessment for Lab Management
• Key changes in ICH Q9
• Practical tips for overcoming common implementation hurdles

• Understanding the product & CQAs
• Risk assessments & protocol development
• Predictive Modeling
• Applications & Considerations
• Industry perspective & regulatory acceptance

• Overview of drug product formulation
• Define guidelines for selection of excipients and target ranges to ensure product quality and safety
• Understand how formulation impacts product stability during manufacturing, shelf-life, and clinical handling
• Understand how formulation selection impacts analytical controls
• Challenges in establishing control strategies in drug product development
• Takeaway Tools:
• Best practices in drug product formulation

• Methods for reducing risk in test method development and use
• How to troubleshoot measurement test methods
• Useful tools: Designed experiments, repeatability and reproducibility studies, robustness experiments and test method stability control
• Risk-based techniques for improving test method performance.
• Systems approach to assess and reduce the risk associated with test method verification.
• Tips and traps for test method development, validation, and improvement
  • Case studies and examples of all methods
• presented
  Takeaway Tools:
• Detailed Article – “Risk-Based Test Method Development, Validation and Life Cycle” – that discusses methods and examples.

• Understand the benefit of an enhanced approach to analytical method lifecycle management
• Identify critical method parameters and use them to inform your design space
• Learn how to right-size your approach to testing based on existing analytical knowledge and risk assessment
• Use QbD principles to create an efficient method monitoring and change management program
• Learn how to leverage the enhanced approach to inform future developments
• Takeaway Tools:
• ICH Q14 Guidance

• Distinction between what should occur during AIQ vs. method validation
• New equipment platforms that challenge the current limits of traditional AIQ validation processes
• Lifecycle and instrument classification advances in theory
• What that means for the future of laboratory validation efforts in the scope of precision/personalized medicine

• Define different types of impurities and degradation products as compared with foreign substances or concomitant components
• Understand the origin of organic impurities and how proper control of impurities leads to good quality medicines
• Discuss how analytical QbD facilitates a systematic and risk-based approach to method development to minimize or removal of organic impurities.
• Discuss how specifications are established for organic impurities in USP monographs.
• Takeaway Tools:
• Define different types of impurities and how they are introduced to the process
• How Quality by Design concept applies to monitoring of organic impurities

• Explore common root causes to analytical lab errors
• Learn different ways to proactively prevent analytical lab errors
• Learn various tools to effectively conduct lab investigations
• Develop steps to minimize errors in analytical testing labs
• Takeaway Tools:
• Example investigation roadmap
• Guidance documents
• Process workflow chart

• Purpose of stability testing of pharmaceutical products – Let’s focus on expiry
• Using the Q1E decision tree to guide extrapolation and statistical analysis decisions
• Principles that underly statistical approaches explicitly defined in ICH Q1E
• Poolability considerations in model fitting
• Interpreting the regression output and making the retest/expiry claim
• Takeaway Tools:
• Decision tree notes to aid in statistical analysis decisions
• Quick guide on poolability criteria and model fitting

• Understand the differences between a chemistry OOS and a microbiology OOS
• Learn key investigation points for a microbiology OOS
• Learn approaches for resampling and retesting
• Perform calculations to determine presence of outlier results
• Conclude the investigation
• Takeaway Tools
• Example SOP
• Example investigation form

• Define requirements and expectations for establishing in-use stability
• Understand considerations for designing and executing in-use stability studies
• Define design requirements for temperature excursion studies
• Understand global market considerations for excursion studies
• Learn how to leverage stability data to support temperature excursions during manufacture, shipment, and storage
• Takeaway Tools:
• List of regulations pertaining to stability excursion studies
• Best practices for designing and executing in-use stability studies

Part 1 – Statistics for Analytical Procedure Development

• Connect statistics to the Analytical Procedure Lifecycle
• Combine risk and knowledge management with Design of Experiments (DOE) to:
  • define the analytical procedure control strategy
  • determine established conditions and method operable design region
• increase robustness
• Variance components analysis to Identify the relieve contribution of sources of variability
  Part 2 – Statistics for Analytical Procedure Lifecycle Management
• Ongoing monitoring using SPC
• Accelerate root cause investigations using data visualization
• Nuances and warnings
  Knowledge Exchange
  Using case study data, attendees identify opportunities to optimize an analytical procedure.
• Takeaway Tools:
• Procedural steps for Design of Experiments
• References regarding the Assumption of Normality for Control Charts

• How to conduct root cause analyses and create sustainable solutions
• Most effective statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc.
• What works and what doesn’t work including illustrative examples
• Information and ideas on approaches that have worked in a variety of situations
• Problems to be on the lookout for and useful solution
• What are the most useful graphical and data visualization methods

Takeaway Tools:

• Detailed Article – “Root Cause Analysis – A Systematic Approach” that provides methods and examples

• Prepare a mock audit plan
• Plan the audit scope and objectives
• Select the audit team and schedule
• Conduct the audit opening meeting
• Perform the audit activities Conduct thorough documentation review, including quality manual and SOPs
• Conduct a mock FDA inspection
• Compile findings and report to the management team
• Conduct the audit closing meeting
• Draft a detailed FDA mock audit reportTakeaway Tools
• Audit check list

• Why statistics for stability? Make objective data-driven decisions
• What is a “research question”? Learn how to articulate the analysis purpose
• Graphical practices to rigorous analysis – statistics that stabilitarians need
• Key elements of a statistical consultation: elevate collaboration to avoid rework
• Case study: Follow a research questions from elucidation through analysis to final resultsTakeaway Tools:
• Outline for a statistical consultation: what you (as a stabilitarian) need to bring to the table to ensure you ask for what you need
• Concept map for data collection
• Template excel file for statistical analysis of stability data
• References for statistical guidance and application methodology

• Industry trend in using science risk-based predictive stability approaches
• Challenges of using predictive stability tools at various stages in drug development and life cycle
• Case studies during new drug development stage
• Case studies during post-approval stage
• Takeaway Tools:
• White papers
• Example of predictive stability tools
• Case Studies publications

• Understand the impact of analytical method changes on CMC development, including comparability, stability trending and specification setting
• Discuss statistical approaches to detect bias between analytical methods, including method bridging study design, power analyses and equivalence vs. difference testing
• Establishment of equivalence margins and performing two one-sided equivalence tests
• Considerations when evaluating the impact and root cause of method bias
• Overview of strategies to control for method bias, including applying correction factors and retain sample testingTakeaway Tools
• Methodologies to evaluate bias
• Method bridging case studies

• Map a standard microbiology test and the see unique physical skills required to perform it
• See how the physical skills are shared across test methods, and how mastery of the skills will assure mastery of other methods
• Learn how physical skills are hierarchical in nature, and how additional physical skill set training should only proceed when the current requirement is mastered
• See how introducing safety, efficiency, and empathy inputs or each skill set will shorten turnaround time and decrease retest
• Takeaway Tools:
• A list of microbiology physical skills that must be trained, practiced, and confirmed, and the USP General Chapters that require each
• A description of a practical test per skill set, that the lab should have every microbiologist perform, document and file, as evidence of effective training

• Understanding the Core Principles of ICH Q14 & Changes
• Define the critical components of analytical procedure development
• Review implementation challenges and solutions
• Regulatory compliance & future outlook
• Takeaway Tools:
• How to develop an effective implementation Plan
• Key changes in ICH Q14
• Practical tips for overcoming common implementation hurdles

• History and facts
• Storage and handling
• Studies, Samples, & Shelf-life
• Project Engagement & Active Involvement

• Purpose of transportation studies
• Planning
• ISO 11607 requirements
• Protocol design for medical devices
  • Sample selection
  • Stress conditions – (ASTM D4169)-shock and vibration, compression, pressure changes, temperature, humidity
  • Test selection-ASTM F88, ASTM F2096, ASTM F1929
  • Test acceptance criteria
• Considerations for sensitive drug products or biologics
• Takeaway Tools
• Sample Distribution/Transportation Protocol for a Medical Device

• Define trend analysis in Quality Management Systems
• Understand the importance and purpose of data trending in day-to-day industry
• Data helps us to identify, evaluate, improve, and even eliminate issues that adversely impact quality but how?
• What are the applicable regulatory requirements and industry best practices
• Useful in detecting patterns that could lead to future quality problems, and in anticipating future performance and new drugs
• Takeaway Tools:
• A necessity not a nice to have
• An insight into our product
• Control charts – simple trends and timeseries plot – APQRs

• Identifying reporting needs for different stability stakeholders (internal and external)
• The regulatory foundations – Stability reporting in the ctd
• Reporting product changes, reporting product issues
• Stability in the Annual Product Quality Review
• Efficiency tools for routine reporting
• The future in the cloud
• Takeaway Tools
• Outline and checklist to create formal stability report templates
• Sample table templates
• Useful references and links

• Understand different thresholds to monitor and evaluate organic impurities
• Discuss ICH guidelines impacting organic impurities of new drug substances and drug products
• Review the FDA expectations of establishing acceptance criteria for impurities
• Discuss USP approach and how impurity profiles in pharmacopeia are established
• Understand how flexible monograph concept is developed for organic impurities in USP monographs
  Note: This session will not cover genotoxic impurities or elemental impurities or residual solvents.
• Takeaway Tools:
• A case study to illustrate the concept of Quality by Design for impurities
• A risk assessment road map to monitor organic impurities

We have no choice about getting inspected or audited by authorities and interested parties, but conducting our own is a great way to maximize our chances for success when the official ones come along. Conducting effective audits involves demonstrating our commitment to, and mastery of quality, while discovering our hidden weaknesses, building our skills, and developing confidence along the way.
This session will help us to:

• Look back and around to establish a starting point
• apply risk assessment to establish areas of concentration
• Secure the cooperation of key stakeholders
• Identify critical and susceptible documentation
• Spot liabilities through periodic walk-throughs
• Train a deep bench for hosting audits
• Establish a state of continuous readiness
• Takeaway Tools:
• Five tier risk chart
• List of common citations
• Roster of potential stakeholders

• Considerations for stability chamber selection and purchase
• Calibration
• Review qualification (IQ, OQ, and PQ) of stability chambers
• Learn the importance of chamber re-qualification
• Key SOPs for stability chambers
• Takeaway Tools:
• Sample SOP for Qualification, Calibration, and Maintenance of Stability Chambers
• Article on “How to Investigate Temperature and Humidity Excursions of Stability Chambers”

• Define Data Integrity from the laboratory systems perspective
• Define Data Integrity requirements for collecting data
• Define Data Integrity requirements for evaluating data
• Understand the regulatory landscape around data integrity for laboratories
• Tips for using data integrity tools to drive operational efficiency in the laboratory
Takeaway Tools
• Checklist for lab systems Data Integrity

• Prepare a mock audit plan
• Plan the audit scope and objectives
• Select the audit team and schedule
• Conduct the audit opening meeting
• Perform the audit activities Conduct thorough documentation review, including quality manual and SOPs
• Conduct a mock FDA inspection
• Compile findings and report to the management team
• Conduct the audit closing meeting
• Draft a detailed FDA mock audit report
Takeaway Tools
• Audit check list