2012 - Live webinar on Creating an Effective Contamination Control and Environmental Monitoring Program By compliance2go

This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the Biopharmaceutical manufacturing of sterile and non-sterile products. The webinar will also provide an overview of the Environmental Monitoring (EM) program.

Why should you attend :

Contamination issues lead to lengthy investigations and costly recalls. In recent years there have been a number of FDA actions related to contamination issues. Even the largest pharmaceutical multinationals are not immune, as evidenced by recent recalls of drug products. Creating an effective Contamination Control programs is a key to minimizing these problems and ensuring that your company does not end up as the next TV or newspaper headline.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Areas Covered in the Session:

? Sources of contamination

? Purpose of Environmental Monitoring

? Types/frequency of Monitoring

? Aseptic processing/ Clean Room classifications

? Environmental data testing and results

? Alert/Action limits

? Controlling contamination

Who will benefit: (Titles)

Managers, supervisors and general staff working in the following functional areas:

? Quality Assurance
? QC Microbiology Laboratory
? Aseptic Processing areas Cleaning Services
? Manufacturing
? Facilities
? Facility/Process Design Engineering

About Speaker

Henry Urbach is a Management Consultant, Founder and President of GMP TDC LLC, a training, development and consulting company that caters to pharmaceutical and biotechnology industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of remediation , and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance, quality systems, and aseptic and environmental monitoring techniques. Henry is a founder and President of GMP Training, Development and Consulting LLC (GMP TDC), a New York-based consulting organization serving Life Sciences industries. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP Training and Education Association (GMP TEA)