|Quantity Discounts||1 - 9999|
|1 - 9999|
|1 - 9999|
|1 - 9999|
In some cases, just one stray molecule is all it may take to adulterate — and ruin — a costly batch of your products.
Drug/biologics manufacturing has entered a new era, one where manufacturing tolerances — especially for certain biologics and small-molecule pharmaceuticals — have grown incredibly tight, even as drugmakers rely ever more heavily on far-flung networks of contract manufacturing organizations (CMO).
Balancing the demand to reduce costs through outsourcing and maintaining current good manufacturing process compliance is tough. No one can deny that. But a cross-contamination disaster will cost 10 times the savings you were hoping for. And might cost you your job.
This webinar is an inexpensive insurance policy to assure you have the right CMO for your job and to provide tools to help you manage and audit them going forward.
Mark your calendar for Thursday, Jan. 26, when your questions on cross-contamination and CMO management are answered.
Kevin Rosenthal, Director of Manufacturing, for chemistry-development provider Pharmatek Laboratories Inc., and Stephanie Wilkins, President, PharmaConsult US will present the latest thinking on the subject of cross-contamination as well as some practical guidance for those who may be thinking about building these types of facilities.
In only 90 minutes, Mr. Rosenthal and Ms. Wilkins will share invaluable guidance on:
Like every FDAnews webinar, Controlling Cross-Contamination in Outsourced Manufacturing is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.
Of course, Mr. Rosenthal and Ms. Wilkins will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by time the session ends.
Everyone in your organization with a role in CMO deserves to take part in this event — and they can do so at a cost that won’t break the budget. You only pay one low registration fee per facility, regardless of how many participate — so spread the word.
Cross contamination is readily avoidable with the right facility design, engineering controls and protocols. Make certain your CMOs do things right. Register now.
Meet Your Instructors
Kevin Rosenthal is the director of manufacturing for Pharmatek Laboratories Inc. He has more than sixteen years of experience in pharmaceutical manufacturing organization. Kevin has designed and built multiple cGMP manufacturing facilities including facilities designed specifically for the development and manufacturing of highly potent and cytotoxic compounds. Prior to Pharmatek, Kevin worked in process engineering and product development at Elan Pharmaceuticals and Dura Pharmaceuticals.
Stephanie Wilkins, PE, Lean Six Sigma Green Belt, has over twenty-eight years of professional experience in project management, engineering, risk management and validation solutions for the pharmaceutical/biotech industry including research, development, pilot plant and manufacturing facilities. She is president of PharmaConsult US, Inc., which provides cross contamination and containment consulting to the pharmaceutical industry. Wilkins is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team, ISPE Trainer for Risk-MaPP and was a member of the ISPE International Board of Directors. Wilkins has also is a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE.
Spread the word throughout your organization. Make particularly certain to notify the following key staff:
|Date:||Jan. 30 – Feb. 17, 2012|
|Location:||Your office or conference room (no need to travel!)|
Gather your team for maximum benefit! Your investment is for one dial-in.
Significant tuition discounts are available for three or more sites from
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
Registrations may not be cancelled. Please contact customer service to make any substitutions.
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