Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing

Wednesday, January 8, 2014 at 10:00 AM - 11:00 AM Eastern Standard Time (EST) and
Wednesday, January 15, 2014 at 10:00 AM - 11:00 AM Central European Time (CET)


High-potency manufacturing requires specialized facility capabilities, equipment selection, and manufacturing processes to achieve the desired levels of containment that meet occupational safety requirements. Selecting a contract manufacturing organization to handle your highly potent compound can be a time-consuming and difficult task. Often, much of the difficulty comes from not anticipating the information needs that a CMO requires prior to bringing your highly potent compound into its facility. In addition, identifying the key technical and production capabilities required of a CMO partner is crucial for effective CMO selection and project execution. This 60-minute webcast will examine:
  • The definition/classification of potent compounds
  • The types of toxicology information needed for preclinical and clinical development and commercial production
  • The systems, processes, procedures and capabilities required for handling and manufacturing high-potency pharmaceuticals
  • Strategies for effective project management and execution.

Key Learning Objectives
  • Understand the capabilities for containment, monitoring, waste disposal, analytical, process safety, material handling, and packaging required for high-potency manufacturing
  • Understand the industrial hygiene information, requirements, and operator training and skills needed for the safe handling of potent compounds
  • Gain insight for effective CMO selection, qualification, and collaboration for product launch.

Moderator

Rita Peters

Editorial Director
Pharmaceutical Technology

Speakers:

Dean Calhoun

President and CEO
Affygility Solutions

Kenny McCleary
Senior International ESH Advisor
Evonik Corporation

Register for this FREE Webcast!

 If you have previously registered for this event, please login below:
 Email:
 LOGIN

Registration is required to attend this event. Please register now.
Title*
First Name*
Last Name*
Job Title*
Organization Name*
Organization Address*
Organization Address 2
City*
State or Province*
Zip/Postal Code*
Country*
E-mail address*
Work Phone*
Do you currently have a HPAPI manufacturing requirement?*
Have you used CMOs for HPAPI manufacturing in the past?*
Does your company or organization have exposure control guidelines for HPAPI’s?*
What is your company's primary business?*
What is your function?*
Would you like to opt-out of further 3rd party communications?*
You must have javascript and cookies enabled to complete registration.
 
Please enable Cookies in your browser before registering for the webcast.
 
*Denotes required.
 
REGISTER

Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call (toll free) 1-866-529-2922 at any time, or fax us at 1-218-740-6417. Outside the U.S., please phone 1-218-740-6395.

Contact us by mail at Advanstar Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.