In-house Courses Available From Scott Sutton, Ph.D.

These courses are available in formats and content customized to meet your particular needs.

Manufacturing focus

• GMP for the Manufacturing Environment; 2 day course on GMP (CFR focus) and cGMP (483/warning letter focus) directed at manufacturing personnel for pharmaceutical and/or biological facilities.  This course is tailored to site needs and meets requirements for annual GMP training in a relevant fashion.

  The course examines the topics of:

  • The Development of the CFR Regulations

  • Documentation Requirements

  • Microbiological Control

  • Environmental Monitoring

  • Contamination Control

  • Personal Cleanliness & Aseptic Technique

  • Cleanroom Activities

  • The Logic Behind the Regulations ( 21 CFR 210, 211, 600 and 610)

   

• Environmental Monitoring; 1 day course on the methods and the reasons for environmental monitoring of production facilities.  This practically oriented course is tailored to site needs.  The course covers:

  • The significance of environmental monitoring in a regulated environment

  • Establishing an Optimal Environmental Monitoring Master Plan

  • Designing and Managing a Microbiological Monitoring Program

  • Considerations in Trending EM Data

  • Microbial Identification

  • Cleaning/Disinfection

  
   

• Sterilization Technologies; 1 day course designed to provide an overview of sterilization theory and validation strategies.  Focus is on the science of the process, with due attention paid to industry and regulatory standards.  The topics covered include:

  • D-values, Z-Values, F_o, SAL and other math

  • The care and handling of biological indicators

  • Sterilization by Heat (moist and dry)

  • Sterilization by Irradiation

  • Sterilization by Ethylene Oxide

  • Sterilization by vaporous gases

  • Why is Aseptic Processing Different from active Sterilization Processes

• Microbiology for Manufacturing Management; 1 day course on basic pharmaceutical microbiology for those needing background in the subject (formulators, RA, QC management)  Course covers:

  • What is microbiology?

  • Growth of Microorganisms

  • Microbial Identification

  • Water Microbiology

  • Cleaning/Disinfection

  • Pharmaceutical/Consumer Care Considerations

  • Validation of Microbiological Assays

  • Developing Microbiological Product Specifications

  • Validation of Rapid Microbiological Methods

• Microbiology for Manufacturing Personnel; 3 hour course on pharmaceutical microbiology designed for manufacturing operators.  This course is similar to the manager's course, but in less detail with more emphasis on individual behavior as a tool for contamination control.  This practically oriented course is tailored to site needs.
  
  
  
  

QC Microbiology focus

• Auditing the Microbiology Lab;  1 day course. This is taught from a goal-oriented auditing philosophy.  GMP issues are covered, but the primary focus of the course is recognition of common problems in QC microbiology laboratory operation as well as the development of practical solutions to difficulties in data generation, recording, analysis and effective reporting.

• GMP for the Microbiology Lab; 3 hour GMP training tailored specifically to the needs of microbiology. Course covers basic GMP, guidance documents on microbiology lab operations, and recent FDA 483 activities in microbiology. This course is tailored to site needs and meets requirements for annual GMP training in a relevant fashion.

• Microbial Identification in Environmental Monitoring – 3 hour introductory overview of available technologies and applications for use in the microbiology function.

• Understanding the Harmonized Microbial Limits Tests - 3 hour lecture/discussion format stressing the new compendial chapters, validation, verification and new expectations in USP <1111>.

• Compendial Chapters for the Microbiologist - 3 hour review of USP chapters with relevance to the QC Microbiology Lab.  Course focuses on practical methods to achieve compliance.

• Rapid Microbiological Methods; Overview of RMM specifically tailored to site needs.  Focus is on analysis of needs and generation of User Requirements Document to drive selection and validation of appropriate technology.  Tailored to site needs.

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