This exclusive Pack of webinars contain 7 courses: 1. Laboratory Controls – Anticipate the Systems Based FDA Inspection 2. Analytical Method Validation and Transfer 3. Auditing Laboratory Data Systems 4. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 5. Handling OOS Test Results and Completing Robust Investigations 6. Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 7. Establishing a Product Stability Testing Program Total Duration: 12 Hours


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TOPIC 1TOPIC 2

Laboratory Controls – Anticipate the Systems Based FDA Inspection

Analytical Method Validation and Transfer

Speaker: Danielle DeLucy
Duration: 75 Minutes
Speaker: Kelly Thomas
Duration: 90 Minutes

Agenda:

  • Defining the Systems Based Inspection
  • What are Lab Controls?
  • FDA inspection techniques
  • Why FDA switched to Systems based Inspections
  • Preparing for a Laboratory Audit
  • Training of analysts in proper inspection behavior
  • Review of materials, equipment, tests and assays
  • Inspection Expectations and Results / Real Life citations
  • Responsibilities of QC / QA personnel during the audit
  • Addressing observations or findings
  • Real life citations

Agenda:

Regulatory Requirements/Guidance on Analytical Method Validation
  • Terminology defined: qualification, validation, revalidation and verification
  • FDA, EMA, ICH requirements and guidance

Analytical Method Pre-Validation – Stage 1

  • Analytical Target Profile (ATP)
  • ICH Q8, Q9 and Q10 adherence – Pre-Validation Requirements

Analytical Method Validation Characteristics – Stage 2

  • Specificity, accuracy, precision, linearity, range
  • LOD and LOQ

Test Method Validation Protocol

  • Elements of a validation protocol
  • Pre-planning and planning steps

Test Method Validation Report

  • Elements of the validation report
  • Elements of the validation protocol and the associated final validation report

TOPIC 3TOPIC 4

Auditing Laboratory Data Systems

Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance

Speaker: Dr. Mark Powell
Duration: 60 Minutes
Speaker: Dr. Ludwig Huber
Duration: 75 Minutes

Agenda:

  • Categories of laboratory data system (GAMP)
  • Lifecycle management, archiving and backup
  • What counts as raw data?
  • Protecting the integrity of analytical data
  • General guidance on assigning user privileges
  • Operating system configuration.
  • Application configuration
  • Controls appropriate for chromatography data systems
  • Practices that aid compliance with data integrity requirements
  • Examples from recent FDA warning letters

Agenda:

  • Eight key FDA/EU requirements for integrity and security of laboratory data.
  • How FDA inspectors check integrity and security of data.
  • Most frequent security and integrity issues: going through recent 483’s, EIRs and warning letters?
  • The importance of limited access to ‘individual users’ rather than to groups.
  • FDA compliant definition, acquisition, maintenance and archiving of raw data.
  • Critical integrity and security issues during the entire life of laboratory data: from  data acquisition through evaluation to archiving.
  • Examples how to ensure and document data integrity.
  • Documenting changes of laboratory data: paper, hybrid systems, electronic.
  • The importance of electronic audit trail to document data integrity.
  • Review of electronic audit trail: who, what, when and how.
  • Ensuring timely availability through validated back-up and archiving.
  • Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.


TOPIC 5TOPIC 6

Handling OOS Test Results and Completing Robust Investigations

Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

Speaker: Danielle DeLucy
Duration: 180 Minutes
Speaker: Joy McElroy
Duration: 180 Minutes

Agenda:

Session 1: Guidelines for Detecting an OOS or Atypical Result
  • Definition Atypical or Out of Specification Result?
  • Review of the FDA Guidance for Industry on Investigating OOS Test Results
    • Phase I: Initial Laboratory Investigation
    • Phase II: Full Scale Investigation
  • Root Cause Analysis Methods
    • 5 Whys
    • Flow Charts
    • Checklists
    • Fishbone Diagrams

Session 2: Testing the hypotheses regarding potential root causes

  • Retesting
  • Considering Other Batches

Session 3: Developing a proper CAPA plan to address any Corrective Actions

  • How to properly document findings
  • Example of a proper OOS investigation write up

Agenda:

Session 1

  • Introduction
  • Quality Systems, Paradigm Shift, Global Perspectives
  • QA/QC Validation
  • Risk Assessment

Session 2

  • Measurement, Resolution, Errors, and Uncertainty
  • Regulatory and QS Requirements
  • The Product Life Cycle Concept
  • USP chapter 1058
  • Examples of Various Systems

Session 3

  • Strategies for Validation
  • Documentation /Master Validation Plan

Session 4

  • Training Requirements
  • Examples of Various Systems

TOPIC 7

Establishing a Product Stability Testing Program

Speaker: Dr. David Lim
Duration: 60 Minutes


Agenda Part 1:

  • Introduction of a Stability Testing Plan and Program
    • Applicable Regulation and Requirements
  • General Stability Considerations Applicable to a New Product (i.e. Potency)
  • Storage Conditions
    • Shelf Life Duration of Studies and Expiration Dates
    • Container Closure Requirements
  • Sample Size
    • Sampling Plan
    • Handling and Analysis of Samples
  • Stability Schedule (Suggested Schedules for Conducting Stability Studies)
    • Pre-approval and Post Approval Studies
    • Stability Tests
    • Reformulated Products
    • Accelerated Temperature Studies
    • Test Schedule Information
      • Suggested Time Points and Expiration Dates Based on Testing Time Points
      • Solid Dosage Forms Suggested Test Schedule
      • Liquid and Semi-solid Types Products Suggested Test Schedule
      • Reconstituted Products Suggested Test Schedule
    • Temperatures of Studies Based on the Product Type
      • Room Temperature Studies
      • Elevated Temperature
      • Refrigeration
      • Freezing Temperature
      • Special Humidity Considerations

Agenda Part 2:

  • Analytical Testing Considerations
    • Quality Control Release Assays and Methods
    • Criticality of the Choice of Test that are Stability Indicators
      • Choice of Methods with Meaningful Data or Stability Indicator
    • Method Attributes
  • Stability Testing Protocol Design
    • How to Design a Protocol and a Report
  • Stability Testing Data Management and Trending
    • Trending Data
    • Expiration Dating Extrapolation Using Data
  • Manual versus Automated Data Management
  • Advantages and Disadvantages

You will also get answers to the following tough questions:

  • For a medical device that has storage label of 15-30°C; Are stability studies at 15°C and 30°C or 25°C study sufficient?
  • For a reconstitution study; product has an assigned expiration of 24 months; do I need to do reconstitution at 12 months (6, hours, 12 hours and 24 hours) and at 24 months (6, hours, 12 hours and 24 hours)?
  • What is the accelerated storage for a product with real time storage of -20°C±5C?
  • Is it an industry’s practice to do study one year past expiration?
  • If the regression predicts failure before product expiration, what is the next step to do in stability?


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