Revised System for Expressing Limits
for Carryover Calculations

October 7, 2010

Those of you who follow my writing on cleaning validation know that I use a shorthand way of expressing limits based on L1, L2, L3 and L4. I have recently revised that system so that carryover calculations, whether they are based on a fraction of a dose or a toxicity value, can be dealt with in a more unified manner. This webinar will cover that new system and its rationale.

To celebrate my 10th year in independent consulting, I am offering this webinar at a special rate of only $100 (with an additional $75 if you also want the recorded webinar CD).

This webinar is applicable to all pharmaceutical manufacturers who set limits by a carryover calculation. This webinar will last approximately 60 minutes, and includes a time for questions and answers. The webinar will be offered twice on Thursday October 7, 2010. One time slot is 9:00 am to 10:00 am, and the second is 12:30 pm to 1:30 pm, with all times being Eastern Time (New York City time).

Topics covered

  • Carryover calculations
  • Why L1, L2, etc.?
  • Past systems I have used
  • Why I am changing
  • Revised system

The fee for the webinar is $100 per connection. A connection is one computer and one call in number. You may project from that computer onto a larger screen for multiple attendees. Registered attendees will be provided a link and password to sign in over the internet and a toll call in number to the USA will be provided for voice. The service provider is WebEx, which will allow both verbal and written questions from attendees.

After registration, you will receive a confirming email of your registration. Approximately three days before the webinar you will be emailed an internet link, a session number, a password, and a toll call in number. At that time you will also be emailed a PDF file of the presentation slides, which you can print for note-taking during the webinar. You may sign in and call in up to ten minutes before the start time.

You may also purchase a CD of the recorded webinar for an additional fee of $75 if ordered at the time of the registering for the webinar. An option will be given on the registration form if you want the CD in addition to the webinar itself (note that the CD will sell for $200 if purchased apart from the webinar). If you also purchase the CD, it will be mailed to you approximately 10 days after the webinar.

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