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

• Time

• Travel Expense

• Loss of employee expertise on-side

Meet your training requirements without spending your training budget as Dr. Sutton will come in for an audit/consultation while providing expert training.

An extensive range of training topics can be provided in your facility to maximize your training dollars.  This is a proven program that has been used by many companies, from international giants to contract laboratories.

Investigations of Microbiological Data Deviations

This course focuses on the investigation of excursion and laboratory test data deviations as a separate portion from the corporate OOS investigations.  The microbiology investigation is specifically excluded from the FDA OOS guideline, but no guidance is provided by the Agency in how to evaluate these events.    Accompanied by real-world case studies, this course will present a comprehensive approach to determining the significance of an event, its root cause, corrective action and a means to determine the effectiveness of the corrective action.  The course focuses on Microbiological Data Deviations (MDD) such as Environmental Monitoring excursions, bioburden results and finished product test excursions such as the Microbial Limits Tests, microbial identifications, Sterility Test failures and antimicrobial Efficacy test failures.   

Contamination Control

This course focuses on the different paths that microbial contamination can enter the production process and how this introduction might be prevented in both the sterile and the non-sterile manufacturing arenas.  Beginning with a review of basic microbiology, this course provides a recommendation of the steps to take to monitor the production process from acquisition of raw materials through product release.  Included is instruction on how to generate a functional and useful risk analysis scheme for your facility and product process to either design control and monitoring processes into your facility, or to serve as a basis for process improvement.

CGMP (Pharma)

This course is presented in several formats and is high customizable to the needs of the facility.  All versions are designed to satisfy the annual GMP requirements of a facility.    The course is customizable to be specific for either sterile or non-sterile operations.

• Manufacturing/Operations
  This GMP course provides a background of the GMP from a historical perspective leading up to current regulatory expectations as demonstrated in warning letters.  The course emphasizes the control of microbial contamination as a primary GMP goal for the production process, and how the process, operators environment and Quality department all play a role in the production of consistent and safe product.  This course can be designed to serve as and annual reminder course (3-6  hours) or a more in-depth discussion of 2-3 days (6 hour days)
• Microbiology Lab
  This GMP course is suitable either for a contract laboratory or an in-house microbiology lab and presents the GMP in terms directly applicable to the technical function.   Due to the nature of the GMP in a technical environment, this course can be easily modified to assist auditors in preparing for a microbiology audit.  This course ties the technical activity of the pharma microbiology lab to the CFR requirements.   Fully customizable to the needs of the facility, this basic course is one day (6 hours) and can approach the GMPS from several different perspectives including:
  • Historical
  • Current Regulatory Activity
  • Preparing for an Audit

QC Microbiology

This course is designed to provide a background to the role of QC microbiology in the Quality process of product production.  The QC microbiology group should play a central role in product quality from facility design and qualification, raw material and process controls and finished product release testing.  This course is an excellent introduction to the QC microbiology function and can be customized to the needs of the facility to provide a complete introduction and discussion or an overview of the topic.

Potential course topics:

1. v  Manufacturing Focus -

   1. Ø  Contamination Control

   2. Ø  GMP

   3. Ø  Environmental Monitoring  (both for aseptic and for non-sterile processes)

   4. Ø  Aseptic Processing

   5. Ø  Microbiology for Manufacturing

   6. Ø  What is the FDA and its role?

2. v  Microbiology Lab Focus -

   1. Ø  The United States Pharmacopeia & Microbiology

   2. Ø  Auditing the Microbiology Lab (contract lab or QC support)

   3. Ø  GMP for the QC Microbiology Lab

   4. Ø  Understanding the USP Tests

   5. Ø  Investigations of Microbiological Data Deviations (OOS)

   6. Ø  USP Chapter <1117> Best Microbiological Lab Practices

   7. Ø  Validation of Alternate Microbiological Methods

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