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

Held Jan. 26, 2012

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 audio CD/transcript 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.

Kevin Rosenthal, Director of Manufacturing, for chemistry-development provider Pharmatek Laboratories Inc., and Stephanie Wilkins, President, PharmaConsult US 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.
Cross contamination is readily avoidable with the right facility design, engineering controls and protocols. Make certain your CMOs do things right. Order 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.

Order 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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600