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Overcoming the Biopharma Skills Gap

The underlying reason for regulatory observations citing various types of personnel-associated deviations is that staff are better trained on paper than through hands-on practical experience. However, the focus on training has been more on compliance with regulations and less on the efficacy and success of transferring practical skills. Closing these skill gaps and resolving the associated drawbacks necessitate a thorough review and rethinking of current training practices established in the biopharmaceutical industry.

From a regulatory point of view, Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, Section 211.25 on personnel qualification, states that each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience (or any combination thereof) to enable that person to perform the assigned functions. The same is required in EudraLex Volume 4 Chapter 2 on Personnel.

Hélène Pora at Pall Biotech, Alain Pralong at Pharma-Consulting ENABLE, and Arnaud Schmutz at Sourcin (October 2019)

Keywords: Biopharma, skill gap, training, education, digital technoloy, regulations, good manufacturing practice, GMP

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