Hach | FREE Continuing Education Course with LSUG

FREE Continuing Education Series on
Pharmaceutical Water and Cleanroom Verification

Review International and US standards and guidances to meet regulatory expectations.

TECHNICAL PROGRAM

8:00 Registration

Track 1
Pharmaceutical Water Systems Monitoring*

8:30		Introductions and Agenda Program Review
8:45		Water System Components and Methods for Reducing TOC and Conductivity Impurities in Purified Water and WFI (Siemens)
9:30		USP & EP Compendia Requirements for TOC and Conductivity
10:15		Break
10:30		Efficiencies of Point-of-use Endotoxin Testing for Biopharmaceutical Water Systems (Charles River)
11:15		Manufacturing Time and Cost Savings by Implementing FDA PAT Guidelines for On-line Release of USP Water for TOC and Conductivity
12:00		Lunch (Compliments of Hach Company)
1:00		In-Line UV for Reduction and Elimination of TOC, Residual Chlorine and Chloramines (Aquafine)
2:00		Break
2:15		Advantages of Ozone Sanitization of Pharmaceutical Water with In-line Monitoring to Reduce Cost
2:45		Automated Monitoring of the CIP Process Results on the Production Floor to Increase Manufacturing Up Time and Reduce Waste and Cost
3:30		Reception, Expo and Prize Drawing

Track 2
Cleanroom Regulations and Monitoring*

8:30		Introductions and Agenda Program Review (Hach Company)
8:45		Optimizing Sampling of Airborne Particle Counts (Hach Company)
9:30		Recent and Pending Changes concerning Airborne Particle Counting - ISO 14644-1, Annex 1, ISO 21501 (Hach Company)
10:15		Break
10:30		Detection of Viables with Real-Time Optical Technology (BioVigilant)
11:15		Compliant Monitoring and Control of Viable Contamination (Veltek)
12:00		Lunch (compliments of Hach Company)
1:00		Cleaning and Cleaning Applications for Product Contact Surfaces (Veltek)
1:45		Particles in Liquids: Sampling Techniques and "How to's" Satisfying USP<788>
2:15		Break
2:30		Enhanced Sampling of Endotoxins on the Production Floor (Charles River)
2:45		Integration and Automation - Getting It All Together: Industry Trends & Case Studies
3:15		Integration and Automation - Getting It All Together: Defining your Requirements
3:30		Reception, Expo and Prize Drawing

*6 hours of GMP training credits.
Certificates available upon course completion.

FALL 2010 PROGRAM REGISTRATION

» San Juan, Puerto Rico – Thursday, September 9
» Columbia, Maryland – Tuesday, September 21
» Arlington Heights, Illinois – Thursday, September 23
» Kansas City, Missouri – Tuesday, October 12
» Toronto, Canada – October 14, 2010

Questions? Contact Donna Ledwick: 541-472-6508.

Participating Companies Include:

• Hach Company – Manufacturer of Anatel, HIAC, Met One and Orbisphere Products
• Aquafine – Manufactures TOC reduction, chlorine destruction, disinfection and ozone reduction systems
• BioVigilant Systems, Inc. – Inventors of instantaneous microbial detections systems for environmental
air monitoring
• Charles River Laboratories – A global company committed to supporting drug development with rapid,
innovative endotoxin assays that save time and improve efficiency
• HEPA Filters – Testing and certifying filters in place
• Siemens Water Technologies – Delivers water and wastewater treatment systems and services
• Veltek – Developing and implementing a viable environmental monitoring program