Risk-based Approach to Biopharmaceutical Method Transfers

Speaker

Instructor: Jeffrey Staecker
Product ID: 705049

Location
  • Duration: 60 Min
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

Why Should You Attend:

The webinar will describe current industry practices and regulator expectations (FDA focus) and how a risk-based approach to method transfers can make transfers. A risk-based approach to method transfers maximizes probability for success while “right-sizing” size of study used to support method transfer. A risk-based approach leverages knowledge, platforms, and analytical menu to minimize size of study where appropriate. It can also minimize business risk by designing a transfer program that minimizes the chance of product failures due to bias or imprecision introduced by the transfer. This approach is easily integrated into the quality system as part of analytical lifecycle management utilizing standard risk-based procedures currently part of all Quality Systems. In addition, presenter will share 25 years of experience working at manufacturers, CMOs, and CROs to help understand the challenges of transferring methods to different types of organizations.

Presenter will bring comments from regulators and industry leaders from January 23, 2017 CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry”

Areas Covered in the Webinar:

  • Regulatory expectations for method transfer
  • Use of a risk-based strategy for method transfer
  • Fitting method transfers into the larger Quality System
  • Importance of method monitoring as part of the overall transfer strategy
  • Introduction of the idea of an “Analytical Target Profile” to focus thoughts on method transfer.

Who Will Benefit:

  • Individuals designing method transfers
  • QA
  • Regulatory professionals
  • Technical representatives for groups involved in method transfers
  • Business leaders needing to understand business, technical risks, and needs for method transfer
  • Supervisors and managers
Instructor Profile:
Jeffrey Staecker

Jeffrey Staecker
Principal Consultant, BioPhia Consulting

Jeff Staecker has worked in GMP industries for over 25 years whose experience covers a breadth of functional responsibilities (QC, QA, R & D, manufacturing) as well as working for manufacturers, a contract testing organizations, and contract manufacturing organization. Responsibilities have included oversight of groups of more than 70 individuals, large budgets, as well as individual responsibilities such as leading risk assessments, technology transfer, and consent-decree remediation activities. Jeff has had multiple roles in method transfers for more than 20 years and recently (January 23) co-chaired and presented at an international meeting “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” (http://www.casss.org/page/CMCJ1700).

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method