cGxP

Consulting

 

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cGxP has established a reputation in the following areas:

A  B  C  D  E  F  G  H  I  L  M  N  O  P  Q  R  S  T  U  V  W 

A

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C

  • Calculations and Rounding

  • Calibration

  • Capital Project and Budget Management

  • CE Mark

  • Certification Procedures

  • Change Control System

  • Characterization (Process and Test Method)

  • Chemical Process Optimization

  • Chromatography Data Systems

  • Cleaning validation

  • Clean-In-Place

  • Clinical Research Support

  • Commissioning

  • Complaint Handling

  • Compliance

  • Computer System Validation (PEMS/LIMS/COTS/PLC)

  • Corrective and Preventive Action (CAPA)

  • Critical Systems

 

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D

  • Data Systems Auditing

  • Design and Engineering Reviews, Product Development Reviews

  • Design Controls

  • Design of Experiments

  • Design Review

  • Development of Control Requirements

  • Development of System Specifications

  • Deviations (planned vs. unplanned)

  • Document Management & Documentation Systems

  • Drug safety review/reporting

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E

  • Electrical Systems

  • Electronic Assembly (PCB and component assembly)

  • Electronic Signatures: Part 11

  • Employee training

  • Engineering Design

  • Environmental Monitoring

  • Equipment and Facility Controls

  • Equipment qualifications

  • EtO Sterilization

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F

  • Facility (Clean Rooms) qualification

  • Facility and Process Engineering

  • Facility Maintenance

  • Facility Monitoring Systems (FMS)

  • Failure Investigation and Trending

  • FDA 483/Audit Responses

  • Field Service

  • Field Trials

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G

  • Global Regulatory Submissions and Registrations

  • Good Documentation Practices

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H

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I

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L

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M

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N

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O

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P

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Q

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R

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S

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T

 

  • Test Method Characterization and Development

  • Test Method Equivalency

  • Test Method Suitability for Use

  • Test Method Transfer

  • Test Method used in Support of Cleaning

  • Test Method Validation

  • Training

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U

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V

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W

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