Analytical Method Validation for Pharmaceutical Quality Control

2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9044)

Analytical Method Validation for Pharmaceutical Quality Control


Mark Powell Scientific Limited

September 13 – 14, 2018

Zürich, ZH, Switzerland


Seminar DescriptionAgendaSpeakerPricingVenue
Analytical method validation is an important activity in support of applications to market a new drug or generic drug product. This workshop will present best practices for method validation during early-stage development as well as regulatory expectations for early and late-stage clinical studies. Method validation for drug substances, drug products, cleaning validation/verification and bioanalytical analysis will be covered. Experimental approaches for key validation parameters will be discussed, and the taught material will be supported by practical exercises.

In addition to the practical aspects of method validation, a logical approach to setting defendable acceptance criteria will be described. Best practices for writing methods and validation protocols will be discussed, including actions to reduce the chances of validation failure and approaches to addressing failures if they occur.

Course Objectives:

By the end of the workshop attendees will:

  • Be familiar with regulatory guidance on analytical method validation
  • Understand how to plan and execute a phase-appropriate method validation study
  • Know how to approach setting method validation acceptance criteria
  • Understand the importance of effective method and method validation documentation
  • Know how to approach setting system suitability criteria
  • Understand the importance of verifying compendial methods and know how to approach this activity
  • Be familiar with allowable changes to method conditions for compendial chromatographic procedures

Who Should Attend
Directors, VP’s, Administrative Staff, Managers and Supervisors in:
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Validation Specialists
  • Analysts and Other Laboratory Staff
  • Lab Supervisors and Managers
  • Analytical Development
  • Bioanalytical Methods
  • GLP/GCP/GMP Auditors
  • DAY 1:

    Lecture 1: Regulatory Guidance on Method Validation

    • ICH Q2
    • US, EU and WHO and other guidance
    • Guidance on bioanalytical and cleaning verification methods

    Lecture 2: Definitions of Validation Terminology
    Lecture 3: Setting Validation Acceptance Criteria

    • Assay, Impurities, Dissolution and Content Uniformity
    • Regulatory expectations
    • Consideration of drug product specifications
    • Measurement uncertainty

    Lecture 4: Experimental Approaches to Method Validation

    • Demonstrating specificity
      • Known API degradation pathway / degradation products available
      • Unknown API degradation pathway / degradation products not available
      • Placebo/reagent/synthetic impurity interference
      • API/drug product stress study design (including peak purity evaluation)
    • Demonstrating linearity Best Practice
    • Accuracy and precision – spiked matrix vs. real samples
    • Sensitivity
    • Robustness
    • Which experiments to perform?
    • Setting sensible robustness criteria (including in-house IVR method)

    Lecture 5: Phase-Appropriate Method Validation / Verification

    • Early stage (focus on specificity, solution stability, filter recovery, logical recoveries for real samples, evaluating accuracy and precision)
    • Phase 1 (focus on safety of clinical subjects)
    • Late stage/commercial

    Exercise: Setting Method Validation Acceptance Criteria

    DAY 2:

    Lecture 1: Writing effective validation protocols and reports

    • Is the method ready for validation?
    • Structure
    • Mistake-proofing (identifying and mitigating risks)
    • Results template
    • Contingency planning
    • Action in the event of validation failure

    Lecture 2: Setting System Suitability Criteria

    • Regulatory expectations
    • Taking criteria from method validation results

    Lecture 3: Verifying Compendial Procedures

    • HPLC (including common mistakes, pitfalls and opportunities for faster analysis)
    • Approaches for other techniques (pH, osmolality, viscosity and Karl Fischer titration)

    Discussion: Case studies and examples
    Exercise: Planning a Validation Study

    Dr. Mark Powell

    Mark Powell Scientific Limited

    Dr. Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

    He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

    For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
    Regular Price – $ 1500

    Group of 3 Delegates – Get 10% Discount (Save $ 1260)
    Group of 5 Delegates – Get 20% Discount (Save $ 2700)

    Early bird seats are limited and based on first-come, first-serve.

    For discounts on multiple registrations, contact customer care at +1-416-915-4458


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    • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

    Hilton Zurich Airport

    Zurich, Switzerland | September 13 – 14, 2018


    Call for Assistance: +1-416-915-4458