Validating rapid microbiology methods Old adult cam
The validation, approval, and implementation of rapid and alternative microbiological methods has been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries.Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.* For this member type or discounted rate, online registration is not available and must be faxed in. You must have this confirmation letter to be considered enrolled in a PDA event.If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed.
The validation assures equivalency of the new method to the reference method.If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not.It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site. Validation of alternative Microbiological Methods; the European pharmacopeia chapter 5.1.6 Alternate Methods for control of microbiological quality, and Rapid Microbial Method of the Japanese Pharmacopeia JP17, mainly.However, the implementation of such kind of technologies remains difficult in user’s labs due to the numerous steps, limiting their usage despite the high added value of these methods in the quality control of products, process facilities and all together increasing patient safety.
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