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Analytical Method Qualification Validation, Verification, and Transfer for Biotechnological Products

Nov 01 - Nov 02, 2018 |
Nov 02, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This interactive course will provide a practical and detailed overview how to consistently perform risk-based analytical method qualification and validation for all method and product lifecycle steps. The course attendants will understand how risks can be consistently assessed from available data sources and how this can be applied to each method lifecycle step. Options how to control risks will be illustrated for each ICH Q2(R1) method category, various production process steps (raw material, in-process, final product), and product life cycle steps (clinical phases I-III, commercial). Specifically, the course will provide detailed strategies and case studies for suitable risk assessments for all method lifecycle steps and the resulting studies and protocol acceptance criteria. The course content builds on ICH and local US and EU guidance documents with the intent to provide more practical guidance.

Regulatory-approved strategies for validation master plans, method qualification, verification, transfer, comparability (replacing method), validation continuum, and how to deal with failed protocol acceptance criteria will be presented with several case studies. Specific considerations for risk-based acceleration of analytical method qualification, validation, verification, and transfer options to support accelerated product development will be provided. Opportunities to use prior experience (analytical platform technology (APT)) to support accelerated product development and process validation studies will be discussed and case studies provided.

In the last part of this course, appropriate recovery options will be illustrated for those rare events when validation failures occur. An overview will be provided how analytical method performance capabilities contribute to the revisions of product specifications and are used in product out-of-specification investigations. At the end of this course, the attendants will be able to generate suitable protocols and acceptance criteria. Future regulatory submissions will be more robust and regulatory inspections can be readily passed.

Who Should Attend

This course is for QA/QC personnel, CMC project managers and technical expert and CMC regulatory reviewers, as well as personnel in regulatory affairs, biotechnological and analytical development, validation, manufacturing, and research and development.

Upon completion of this course, you will be able to:

  • Maximize the value of all method lifecycle steps for typical and accelerated product development
  • Develop strategies and the study designs for qualification and validation studies for various types of analytical methodologies
  • Use effective and compliant pre-validation method robustness and DOE study designs
  • Develop risk-based strategies and case studies for pre- and post-validation method transfers
  • Use suitable verification study models
  • Prepare appropriate method comparability study protocols when replacing analytical methods
  • Write defendable protocols and reports using risk-based protocol acceptance criteria
  • Use suitable statistical tools for each method lifecycle step
  • Use suitable recovery options for validation failures when they occur
  • Use analytical method capability when setting process/product acceptance criteria and dealing with OOS events



On or before September 14, 2018

After September 14, 2018


On or before September 14, 2018

After September 14, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 1, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Stephan Krause, Director of QA Technology, AstraZeneca Biologics

Dr. Stephan O. Krause has held leading roles for quality and regulatory functions for several biotechnological firms. Currently, he is AstraZeneca's Director of QA Technology in their commercial biologics operations. Stephan has published many articles in respected industry journals in the US, Europe, and Asia. His book on risk-based method validation strategies (PDA/DHI Publications, April 2007) won the PDA Distinguished Author Award in 2008. This yearly industry award recognizes significant contributions to improve industry standards. Stephan was the primary author and task force leader of PDA TR 57 (2012), co-author of PDA TR 65 for Tech Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015). He was invited and presented to FDA/OBP in 2012 and 2015 an industry perspective for analytical method lifecycle steps for routine and accelerated (biosimilar) biological product development. He is currently PDA’s biosimilar initiative co-leader and is a member of PDA's Biotechnology Advisory Board and Education Advisory Board.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #477 | ACPE #0116-0000-16-043-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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