Extractable & Leachable Studies

You will be given a comprehensive overview of how to perform a good Extractable & Leachable Qualification in order to ensure the Quality and the Safety of a Drug Product.

Presenters will focus on Regulatory Requirements from FDA and EMA and on the Techniques to assess the level of Packaging residues on Products.

Analytical considerations for a wide variety of input will be discussed: Compendial Tests, Studies on Disposables in Bioproduction, E/L Testing for different Systems of Applications (Inhalation, Parental, Ophthalmic).

An extensive use of Case Histories will help you to assimilate the knowledge and to capitalize on experiences illustrated.

IIR Course is the only one Training Program you can take in Italy in order to get a 360° Practical Preparation on Extractables & Leachables.