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

Nov 01 - Nov 02, 2018
Bethesda, MD

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.

  • Education
Closed
Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

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.

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Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend

    Who Should Attend

    More information coming soon.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

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Registration Fees

Regular Price

Standard

Member

On or before September 14, 2018
$1,743

After September 14, 2018
$1,937

Nonmember

On or before September 14, 2018
$2,092

After September 14, 2018
$2,324

Government/Health Authority/Academic

Member

$1,162

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 [email protected] 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.

Location

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

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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