1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
The Technical Regulatory Expectations
in Development and Manufacture of Biotherapeutics
A 3-Day Intensive Continuing Education Course 1.8 CEUs)
The path from the discovery of a new biopharmaceutical drug to its commercial production is mostly narrow, steep, thorny and filled with many obstacles. Some of these obstacles are created by the regulatory requirements which rightfully demand proof of safety, potency, efficacy and stability of the new drug and proof for a reliable manufacturing process and a stable, well-controlled production environment that minimizes the risk of product contamination. The fulfillment of these regulatory requirements can easily become overwhelming, unless everybody involved in development and manufacture of the new therapeutic knows from the onset what will be required when, how and why.
This course will teach the reason why the requirements are what they are and how and when in the development process they should be addressed to
ensure a swift development process that meets regulatory expectations.
THIS COURSE WILL IMPROVE YOUR KNOWLEDGE OF...
the concerns and expectations of regulatory authorities
how to establish and qualify the Master and Working Cell Bank
how to properly document the development progress
how to set up an effective documentation system
how to validate analytical methods
how to develop specifications for raw materials, components, cell line, in-process material and product
methods used for cell line and product characterization
how to develop a production process and determine process specifications
how to handle and qualify materials and their vendors
…AND WILL TEACH YOU THE BASICS OF
proper facility design
setting up the basis for a functioning quality system
facility and process validation.
Copyright Center for Continuous Education