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2-day In-person Seminar

Analytical Method Validation for Pharmaceutical Quality Control

Instructor
Mark Powell 

Seminar Id

300003

Date

14 & 15 May, 2018

Time

09:00 AM To 05:00 PM CEST

Location

Zurich, Switzerland

Venue

Hilton Zurich Airport

Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00
Register for 5 attendees
Price : US$3,597.00     Save: US$2,398.00 (40%)
Register for 10 attendees
Price : US$6,594.50   Save: US$5,395.50 (45%)
Refund Policy


**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Why you should attend

The use of appropriately-validated test methods is an essential requirement of Good Manufacturing Practice. This course provides an overview of current regulatory guidance, as well as practical advice on planning and executing method validation and verification studies. Group exercises and case studies are used to reinforce learning.

Areas Covered in the Session

  • Understand regulatory expectations for method validation/verification
  • Be familiar with validation terminology and experimental approaches to method validation
  • Know how to write effective test methods and validation protocols
  • Be able to set meaningful acceptance criteria
  • Understand the extent of method validation required at each stage of development
  • Have strategies for dealing with validation failures
  • Understand how to set system suitability limits

Who Will Benefit

This course is intended for personnel involved in pharmaceutical method validation or the verification of compendial methods.

  • QA/QC Managers and Personnel
  • Validation Specialists
  • Analysts and Other Laboratory Staff
  • Lab Supervisors and Managers
  • Regulatory Affairs
  • GLP/GCP/GMP Auditors
  • R&D

Agenda

Day 1 Schedule

Lecture 1: Regulatory guidance

  • ICH Q2
  • US, EU and WHO guidance
  • Requirements for Phase 1 studies

Lecture 2: Definitions of validation terminology

Lecture 3: Setting validation acceptance criteria

  • Setting criteria based on critical quality attributes
  • Measurement uncertainty
  • Typical API acceptance criteria
  • The role of risk management/evaluation

Lecture 4: Experimental approaches to method validation

  • Typical experimental designs
  • Stress studies

Lecture 5: Phase-appropriate validation

  • Suggested approaches for early and late-stage studies

Exercise - setting method validation acceptance criteria

Day 2 Schedule

Lecture 1: Writing effective methods, validation protocols and reports

  • Preparing for method validation
  • Documentation
  • Mistake-proofing methods and protocols

Lecture 2: Dealing with validation failures

  • Prevention
  • Contingency planning

Lecture 3: Setting system suitability criteria

  • Typical parameters
  • Using robustness data

Lecture 4: Verifying compendial procedures

  • Minimum requirements
  • Appropriate tests
  • Method verification protocols
  • Verifying chromatographic methods

Case studies

Exercise - planning a method validation study

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Mark Powell 

Director,
Mark Powell Scientific Limited


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.

Venue

Location: Zurich, Switzerland
Hotel: Hilton Zurich Airport