This webinar will focus on the basic issues involved in setting limits for active ingredients in cleaning validation protocols. This is often called the Maximum Allowable Carryover (MAC or MACO) calculation. Variations on how it is presented or expressed by different companies will be presented. Specific situations in which a safety factor other than 0.001 might be used will be explored. Handling of unique situations like adult/child doses and doses based on body weight (or skin surface area) will be covered. The proper use of “default values” will be explained, as well as alternatives to use for default values. The regulatory basis for these calculations will be discussed.
This webinar is applicable to all pharmaceutical manufacturers who set limits by a carryover calculation. This webinar will last approximately 75 minutes, and includes a time for questions and answers. The webinar will be offered only twice on Thursday February 25, 2010. One time slot is 11:00 am to 12:15 pm, and the second is 10:00 pm to 11:15 pm, with all times being Eastern Standard Time (New York City time). The Thursday morning slot will allow for participation by companies in Europe. The Thursday evening slot will allow for participation by companies in Australia and Asia (as this is during working hours on Friday, February 26 for those locations)
The fee for the webinar is $350 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 $100 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 $450 if purchased apart from the webinar). If you also purchase the CD, it will be mailed to you approximately 10 days after the webinar.
On the next page, click on “continue” in the lower left to enter the credit card information
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be sure to add your company name where it asked for.