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Managing Training for a Global Workforce: Best Practices from Leading Life Science Companies
“The Commission/EMA and the FDA continue to share experience with a view towards determining the best international approach to the extent to which dedicated production facilities may be necessary ... taking into account a risk based approach."
Medicines Regulation: Transatlantic
Administrative Simplification Action Plan
Implementation report - 2009
The EU-EMA/FDA bilateral announcement cited above provides a valuable illustration of the regulatory harmonization effort occurring across several continents. As the world’s top regulatory bodies adopt a harmonized approach, life science companies are taking a similar global approach to compliance and quality training.
A recent article from the European Compliance Academy posed the question, “why are there more and more serious GMP deficiencies on the basis of inspections?”
