Learn the history and proper use of the mean kinetic temperature calculation in GxP manufacturing and distribution, including an overview of regulatory guidance from the FDA, EMA, and ICH.
When we asked our customers and industry contacts: "Do you use MKT in a regular workday?" Over 31% said: yes. Surprisingly, almost 5% of people said they were unsure how to use the calculation at all and roughly 63% said they didn't use it very often, but wanted to understand where and when to use it. This webinar was created for people in all three groups - experienced, curious and uncertain.
In this webinar we outline the history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution. We will include an overview of the regulatory guidance on MKT from the FDA, EMA, and ICH.
Vaisala's Senior Regulatory Expert Paul Daniel provides you with 6 clear Do's and Don'ts for using the Mean Kinetic Temperature calculation, including where it is useful in decision-making for regulated industries, and where it is not. Participants will leave the webinar with an understanding of MKT as a non-linear weighted average that shows the effects of temperature variations over time. You will leave this webinar familiar enough with the MKT value to be able to use it to interpret their own data and explain their decisions to an auditor.
Key Learning Objectives
- References and resources for MKT calculation
- The Arrhenius equation and the non-linear effect of temperature excursions
- How regulatory bodies (like the FDA and EC) recommend MKT
- What data to use when MKT is not appropriate
- Facilities manager
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- Regulatory officer
- Distribution Manager
- Warehouse Manager
- Logistics Manager
- Stability Scientist