In this webinar we outline the history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution. We also discuss the regulatory guidance that describes where and when it is appropriate to use the mean kinetic temperature calculation, including FDA, EMA, and ICH.
Vaisala’s Senior Regulatory Expert Paul Daniel will provide 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. For example, if we understand why MKT was originally used to select temperatures for long-term stability studies, then we understand why MKT is suitable for evaluating the long-term temperature performance of ambient storage areas.
Webinar participants can ask about best practices for the MKT calculation in their controlled environments and will become familiar enough with the value to be able to use it to interpret their own data, and explain their decisions to an auditor. Register today!
Paul Daniel,
Senior Regulatory Expert
Paul Daniel, Senior Regulatory Compliance Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries. Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820. An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor's degree in biology (with honors) from the University of California, Berkeley.
- 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
- Calibration manager
- Validation manager
- Validation specialist
- Validation technician
- Regulatory officer
- Distribution Manager
- Warehouse Manager
- Logistics Manager
- Stability Scientist
