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• Validation
  

  Pharmaceutical Process Validation: Product Quality, Safety and Efficacy

  Validation must happen at each step of a manufacturing process.

  Robert Glaser, CTO, Auvesy, Inc 09.16.19
  

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• Biologics, Proteins, Vaccines | Process Validation
  

  Process Validation in Biologics Development

  Strategies for successful process validation in the wake of faster approval timelines.

  Victor Vinci and Claudia Berdugo-Davis, Catalent Biologics 05.07.19
  

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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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• Drug Development | GMPs/GCPs | QA/QC | Validation
  

  Validation, Qualification and Calibration

  What should a pharma company look for in an outsourcing partner?

  Marco Benvenuti, Business Manager, SGS Life Science Services Italy 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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• APIs | Aseptic Processing | Biologics, Proteins, Vaccines | Cleaning Validation | Extractables and Leachables | Facilities | GMPs/GCPs | Injectables | Laboratory Testing | Methods Development | Microbiology | Process Development | Process Validation | QA/QC | Validation
  

  Aseptic Processing Validation

  Best practices for sterile filtration validation of re-use and extended-use processes

  Ross Acucena and Randy Wilkins 04.04.12
  

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• Validation

  Validation

  The establishment of documented evidence (for example, data derived from rigorous testing) that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality a…

  02.27.12
  

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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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