Thursday February 23, 2012
LIVE Webinar
Reviewing your Cleaning Program Prior to a Regulatory Inspection
Live Webinar
Date: Thursday, February 9, 2012  
Registration Single Attendee: CAD $195.00
Group rates are available. (see below)

All rates are subject to the Canadian 13% Harmonized Sales Tax (HST)
Time: 1:00 PM ET | 10:00 AM PT Duration: 2 hours with Q&A
Areas Covered in the Session

This presentation will address a pre-inspection process that will ensure a comprehensive review of the company’s cleaning program and issues prior to a regulatory inspection.

  • Review of previous comments made by regulatory inspectors and customer audits pertaining to cleaning issues
  • Review of documentation-including validation documentation (master plan, protocols, & reports) as well as cleaning procedures, deviations, CAPA’s
  • Review of strategies and approaches
  • Updating and modernizing plans for the cleaning program
Learning Objective

The main objective is to create recognition that, even though an inspection is imminent, there is still time to make small changes and bring the cleaning program up to speed in order to prevent or mitigate regulatory citations.

Who Should Attend

Those individuals who can be expected to host inspections/audits as well as those individuals who may interact with inspectors such as QA/QC, validation personnel, and regulatory affairs.

Speaker
Dr. William E. Hall
President
Hall & Pharmaceutical Associates, Inc.

Dr. William E. Hall is considered an international expert on cleaning in the pharmaceutical industry. He has been a contributor and innovator of many of the concepts and approaches currently used in cleaning programs today throughout the industry. He has also served as a mentor and teacher of many of those responsible for cleaning programs throughout the world.  He holds a BS from the University of Arkansas and MS and PhD degrees from the University of Wisconsin at Madison.  With more than 45 years’ experience, he has consulted for more than 500 companies worldwide since forming his own consulting company in 1995.  Prior to 1995, Dr. Hall held various positions in Research and Development, Quality Assurance, and Quality Control in Glaxo Wellcome for 22 years and was a faculty member at the University of North Carolina at Chapel Hill, School of Pharmacy for 7 years prior to that. He also served on the faculty of the University of Wisconsin, School of Pharmacy.  He has published extensively in journals and textbooks on the subject of cleaning, process validation and chemical kinetics of pharmaceutical systems and serves on various editorial boards and advisory councils of journals and universities.  He is also a member of the IVT Validation Hall of Fame.  Dr. Hall has given hundreds of presentations on the subjects of process validation, cleaning validation, quality assurance/ compliance, and drug abuse. He also serves as an expert witness for FDA litigation in the area of GMP compliance and has taught FDA inspectors in the evaluation of cleaning programs.

Rates

Single Attendee: CAD $195.00

Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00

Single attendee refers to single participant at a single computer/login.

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.

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