Instructor

Lena Baard

Lena Baard, the founder and proprietor of Florian Consulting AB, boasts over a decade of experience working with sterile medical devices. With a rich work-life background spanning more than 20 years in the Life Science industry, she has gained extensive expertise in both pharmaceutical manufacturing and Medical Device Manufacturing companies.

Lena possesses specialized knowledge in Ethylene Oxide sterilization and aseptic manufacturing of Medical Devices. In her role, she has undertaken the responsibility of establishing and supervising the validation and re-qualification processes within sterilization, encompassing Ethylene Oxide, gamma irradiation, and e-beam sterilization. Additionally, she has assumed the role of QA overseer for aseptic manufacturing of medical device Class III.

Actively engaged in the field of standards and regulations, Lena serves as a member of the Swedish standardization committee (SIS TK 349), contributing to the development of standards related to Cleaning, Disinfection, and Sterilization.

Lena’s expertise extends to various areas of medical device manufacturing, encompassing the sterilization of diverse devices and comprehensive understanding of the corresponding regulatory framework governing terminal sterilization and aseptic processing of medical devices.

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Related courses to Lena Baard

Sterilization of Medical Devices

May 13
- May 17, 2024
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

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