Controlling Cross-Contamination in Outsourced Manufacturing Expert Guidance to Assure CMO Compliance

Quantity Discounts
1 - 9999
1 - 9999
1 - 9999
1 - 9999
Drug sponsors’ #1 concern with contract manufacturers is managing cross-contamination prevention and handling capabilities, according to a recent survey.

One molecule.

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:

  • Determining best practices to prevent cross-contamination issues;
  • Managing and auditing — techniques to assure CMOs are doing things right;
  • Responding to FDA concerns;
  • Cross-contamination concerns now and in the future;
  • And much more.

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.

Register now!

Spread the word throughout your organization. Make particularly certain to notify the following key staff:

  • Manufacturing directors
  • Plant engineering staff
  • QA/QC staff
  • Training managers and coordinators 
  • Operations
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • Executive management
Date: Jan. 30 – Feb. 17, 2012
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
with any questions.

We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

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.

Interested in Becoming a Speaker?
We're always looking for industry leaders eager to share their expertise at an FDAnews audioconference, webinar or physical conference. Our seasoned speaker community includes executives in the pharmaceutical, medical device and clinical trial industries, regulatory affairs, quality control, compliance, healthcare and academia, as well as several former — and current — top FDA officials. Click here to complete our speaker opportunity form and have a representative contact you about future opportunities.