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Agenda
Agenda
Overview
Single-Use Disposable Bioprocessing products have gained rapid acceptance by biopharmaceutical manufacturer worldwide. Single-Use Disposable products have reduced contamination rates, enhanced production throughput and decreased overall operating costs. Recent collaborations between leading filtration, container /closure, mixing and cell culture companies have resulted in fully integrated Single-Use Disposable Bioprocessing platforms and systems.
Description
This seminar presentation examines the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products and will cover:
* Single-Use disposable Technologies, from upstream to downstream processes, are reviewed as related to the use of polymeric devices.
* Specific attention will be given to the related applications used in the
production of biopharmaceuticals and pharmaceuticals.
* How to increase productivity, reduce or eliminate cleaning and
sanitization processes, reduce batch and cross batch contamination.
* Compare the significant material cost savings and reduction in
operational expenses using disposables vs. hardware.
Learning Objectives
At the completion of this lecture course the participant will be able to:
• Identify applications where the use of disposables would be of practical advantage over hardware, e.g., cleaning validation.
• Understand the concepts of disposable technology to assist in writing change control documentation.
• Distinguish changes under the new regulatory process improvement guidelines, minor, moderate and significant.
• Designate which processes and production areas would most benefit from a change to disposable products.
• Describe the multiple cost saving analysis and plans for implementing and justifying the use of Single-Use Disposable Technology.
RATIONAL
Attendees will learn the latest developments in Single-Use polymeric products, devices and their application in replacement of hardware. Practical illustrations will teach the participants the ‘How-to' apply the disposable technologies on their projects and process operations.
PREREQUISITES
It is designed for the experienced as well as those new to biopharmaceutical processes
Who Should Attend
Process Development Engineers and Scientists, Pilot-Plant Operations, Production Management and operation staff.
KEY TOPICS
. Practical Application of Single-Use Technology in bioprocess and pharmaceutical process development and manufacturing.
. Change Control and relative risk analysis and assessment to implement a Single-Use program.
. Regulatory requirements and documentation understanding needed in Single-Use applications.
. Benefits and Cost savings realization from Single-Use programs.
Presenter
A. Mark Trotter, M.Sc., M.B.A
President and Principal Consultant
Trotter Biotech Solutions
Mr. Trotter, with over twenty years experience in the pharmaceutical and life science industries, has a broad range of work experience, from Pharmacologic chemistry R&D project leader in academia to Marketing Management with laboratory & process equipment manufacturers. He presents technical papers, workshops, seminars and training courses relating to biopharmaceutical topics from membrane filtration, Single-Use disposables, utilities, upstream & downstream processing, polymer leachables and extractables, validation, qualification and regulatory/industry requirements and trends. He publishes technical articles, book chapters and contributed expert comment on these subjects. A member of PDA, ASM American Society of Microbiology, SBE Society for Biologic Engineering, American Society of Quality and ISPE.
Registration Fee
Up to & on December 31: $695
On & After January 1: $795
Government/Academic: 20% off above pricing. Please fill out the form and email/fax with proof of employment.
Group rate: Register 4 people and the fifth is free. Please fill out the registration form and email/fax at the same time.
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