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Bioanalytical method validation

ELISA – principles, application, development, qualification

  • Principles of ELISA
  • Antibodies overview
  • Antibodies production
  • ELISA optimization
  • Application of ELISA test
  • Qualification of ELISA methods

Available dates:

2022/10/24 – register

2022/12/19 – register


Walidacja metod analitycznych

Fundamentals of mass spectrometry

  • Ion separation
  • Ionization and ion sources
  • Mass analyzers
  • Mass spectrum overview
  • Fragmentation mechanism
  • Tandem mass spectrometry
  • Application of mass spectrometry

Available dates:

2022/12/05 – register


pharmaceuticals plant

Fundamentals of biologics production

  • Principles of recombinant proteins production
  • Common expression systems (E.coli, yeasts, CHO, HEK)
  • Properties of biologics
  • Upstream production
  • Downstream production
  • Regulatory requirements

Available dates:

2022/12/12 – register


strategy

Analytical strategy and method development

  • Regulatory environment
  • Analytical strategy
  • Criticality assessment of quality attributes
  • Analytical methods lifecycle
  • Analytical Target Profile
  • Method development approaches
  • Analytical method risk assessment
  • Method control strategy
  • On going monitoring

Available dates:

2022/11/07 – register


Walidacja metod analitycznych

Analytical Methods Validation

  • Guidelines for the validation of analytical methods
  • Validation plan
  • Validation protocol
  • Performance of validation
  • Validation report

Available dates:

2022/11/14 – register


Transfer metod analitycznych

Transfer of Analytical Methods

  • Guidelines for transfer of analytical methods
  • Laboratories responsibilities
  • Transfer plan and protocol
  • Transfer execution
  • Transfer report

Available dates:

Currently unavailable


Analytical Method Lifecycle

Analytical method lifecycle management

  • Building an analytical strategy
  • Risk analysis of quality attributes
  • Development of analytical methods
  • Validation of analytical methods
  • Transfer of analytical methods

Available dates

Currently unavailable


Walidacja arkuszy obliczeniowych

Calculation Spreadsheet Validation

  • Approaches to validating spreadsheets
  • User specification of a worksheet
  • Validation protocol
  • Maintaining and documenting spreadsheet validation
  • Locking cells and securing the worksheet
  • Macros and spreadsheet validation

Detailed Training Program

Available dates:

Currently unavailable

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