Search Results for 'Validation'

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• Regulatory Affairs | Serialization
  

  Serialization Validation: Right Fitting Your Strategy With a CMO

  There are three key factors for manufacturers to evaluate as they define and refine their validation and testing approach.

  Linda Kristoffersen and David Colombo, KPMG Life Science Advisors 09.01.17
  

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• A New ASTM Standard for Cleaning Validation

  Wednesday, March 22, 10:30am – 12:30pm INTERPHEX Innovation Stage, Booth 1170, Exhibit Hall A New ASTM Standard for Cleaning Validation Guidelines previously published by ISPE and under development for the past five years are now being com…

  03.01.17
  

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• Excipients | Process Development | Process Validation | Regulatory Affairs | Risk Management | Validation
  

  Process Validation

  Has it changed since the issuance of the FDA and EMA guidances?

  Peter H. Calcott , Calcott Consulting LLC 10.07.15
  

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• Aseptic Processing | Process Development | Process Validation | Risk Management | Validation
  

  Implementing Process Validation Guidances

  Complying with FDA and EU for small and mid-sized companies

  Peter H. Calcott, Ph.D., President, Calcott Consulting LLC 03.06.13
  

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• Validation

  Validation batches

  Validation batches are commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.…

  02.27.12
  

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• Process Validation | Validation

  Packaging Process Validation

  How the DOE approach can smooth the process

  Shamik Pandit 08.23.05
  

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• Bioassay Development | Capsules | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Inspections | Lyophilization | Methods Development | Process Development | Process Validation | Scale-up/Technology Transfer | Solid Dosage/Semi-solids | Toxicology | Validation

  System Validation Requirements

  21CFR11 enables use of electronic records and signatures, but it requires a comprehensive validation program

  Kevin Lloyd 08.22.05
  

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