Services

Good Laboratory Practice Training

Compliance Reviews can can provide training for your study personnel in Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Toxic Substances Control Act (TSCA), Center for Veterinary Medicine (CVM), OECD, and FDA GLP requirements.  We will:

• Provide seminars addressing current requirements
  

• Provide training for beginning and advanced level quality assurance professionals, managers, field and laboratory scientists and technicians 
  

Good Laboratory Practice Quality Assurance

We can support or establish a Quality Assurance Unit (QAU) for you that is tailored to your laboratory and/or field testing needs.  Compliance Reviews will:

• Review protocols for laboratory and field studies for compliance with EPA, FDA, OECD requirements and testing guidelines
  

• Perform all the required functions of a QAU on a full-time, part-time, or as-needed basis
  

• Perform independent in-progress and/or raw data audits
  

• Perform study and/or GLP compliance evaluations at your facility or field site, or at a contractor’s facility
  

• Perform complete final report audits
  

• Review, distribute and maintain standard operating procedures
  

Good Laboratory Practice Program Development

Compliance Reviews can assist you in the setup and implementation of a GLP program for a new testing facility or testing program in agrochemical, medical device or pharmaceutical research environments.  We will:

• Assist in the preparation of standard operating procedures for laboratory and field procedures, equipment usage, facility and administrative procedures
  

• Develop laboratory and/or field data collection forms
  

• Develop record keeping systems such as training forms, master schedules, equipment maintenance logs, test substance receipt forms and chains of custody, etc.
  

• Define personnel organizational structures
  

• Develop job descriptions
  

• Interview potential QA employees and help with their selection
  

• Establish key elements of GLP requirements, such as a quality assurance unit, training files, and archives
  

• Provide GLP training
  

• Provide guidance on all aspects of study conduct, from protocol development through final report preparation
  

• Provide quality assurance functions
  

Computer Validation Program Development

Compliance Reviews will work with your IT department or LIMS provider to establish a 21 CFR Part 11 compliant document management or data collection system.  We will:

• Review and/or assist in the development of validation plans for Livelink document management systems.
  

• Review and/or assist in the development of  validation plans for purchased LIMS.
  

• Develop training programs for end users and IT.
  

• Assist in the SOP development process for User Requirements, Roles, Risk Assessment, Change Control, Test Management, etc.
  

• Develop validation plans for equipment qualification.
  

Pesticide Registration Project Management

For studies submitted to the EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) or the Toxic Substance Control Act (TSCA), we have the capabilities to:

• Help you select testing facilities facilities by evaluation of contractors for regulatory compliance – including review of personnel qualifications, facilities and equipment
  

• Monitor on-going studies
  

• Review or prepare protocols in compliance with testing guidelines and GLP standards
  

• Review, edit and finalize reports to meet the required data reporting guidelines and GLP standards
  

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