The Microbiology Network is a consortium of national experts in GMP, microbiology, GMP, laboratory operations and contamination control that is available to conduct onsite instruction in a variety of topics:
We can provide extensive training in your facility to maximize your training dollars.
All courses can be modified to meet specific requirements for your facility and can be adjusted to last from 3 hours to 2 days, depending on the level of detail desired. The training can be coupled with preliminary audits to provide a powerful, objective tool to focus on specific areas of need in your operations.
Let us provide training in the following critical areas:
This 3-day intensive course provides GMP training tailored specifically to the needs of manufacturing and can be tailored for operators or management. This course was originally designed to meet FDA-imposed training requirements in response to audit findings for a major pharmaceutical company. The course covers basic GMP (and the reasons behind the regulations). This course is not a listing of the CFR regulations but uses them to focus on current practice and the science behind contamination control. This course is tailored to site needs and meets requirements for annual GMP training in a relevant fashion.
These GMP training courses are tailored specifically to the needs of the microbiology and the Quality (contamination control) functions for annual GMP training. All courses cover basic GMP with an emphasis on lab operations and contamination control and are tailored specifically to sterile or non-sterile needs. These courses provide a change from the standard corporate GMP training and an opportunity to discuss topics of specific interest to the functions.
All courses are designed to be three (3) hours in length and completed in either a morning or afternoon session. Before and after course quizes are provided and graded Ceritificates of completion are issued to successful participants for their training records as well as a copy of the quiz, and the presentation materials.
An excellent way to maximize your training budget is to couple the GMP course with an audit of your facility. We will come in, perform an independent audit of the systems of greatest interest to you, and modify the course to emphasize the solutions to the issues observed. This approach focuses on solutions, not merely pointing out the problems, and how to solve the problems so that your staff is capable of preventing recurrence.
This 1-day course is designed for manufacturing managers. This course focuses on the requirements for cleanliness and hygiene in all aspects of the operations as well as the reasons behind those requirements. Different courses available for sterile and for non-sterile manufacturers.
A 2-hour course on pharmaceutical microbiology designed for manufacturing operators focusing on providing an understanding of the need for cleanliness and contamination control. Different courses available for sterile and for non-sterile manufacturers
A 1-day course 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. This course can be developed for your facility from an examination of recent 483 and warning letters, from the perspective of a detailed examination of the CFR and how it affects daily operations, or from an operational perspective. This choice is open to the client.
The fundamental issues associated with investigations in the microbiological area. This course focuses on the laboratory investigation and determination of the validity of the data. The concept of “Microbial Data Deviations” as distinct from OOS is developed along with practical and workable methods for evaluation of the events surrounding the failing results.
An 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.
This course covers the basics of sterilization, aseptic processing and environmental monitoring/control for sterile products.
The production of non-sterile products presents unique challenges. This course reviews non-sterile product environmental monitoring and contamination control procedures (from raw materials through all in-process steps). Finished product testing focuses on the harmonized microbial limits chapters and the CFR 211 requirements for “absence of objectionable organisms.”
A 2-hour introductory overview of available technologies and applications for use in the microbiology function. Excellent for new members of the microbiology function or for QA and RA professionals.
A 3-hour lecture/discussion format stressing the new compendial chapters, validation, verification and new expectations in USP <1111>. In addition, the fundamental difference between the Microbial Limits Tests and the 21 CFR 211 requirements for “absence of objectionable organisms” is examined with guidance on how to determine if an organism is objectionable.
A 3-hour review of USP chapters with relevance to the QC Microbiology Lab. Course focuses on practical methods to achieve compliance.
A 2-day course on basic pharmaceutical microbiology for those needing background in the subject (formulators, RA, QC management).
Create a course of interest to you from the following listing (3 units = ½ day, 6 units = full day). All course components can be customized to your specifications.
Lab Practices / Basic Science
|Microbiology for Manufacturing Personnel||1 to 3|
|Variability of microbiological data||1|
|Microbiological Lab – Best Practices||2|
|Microbiology Lab – Auditing||2 to 6|
|Investigations of Finished Product Testing, Microbiology||3|
|Validation of Alternative Microbiological Methods||2|
|Validation of Microbial Recovery||1|
|Microbiology Finished Product Test Methods (overview)||1|
|Antimicrobial Preservatives – Effectiveness||1|
|Microbial Limits Tests (USP <61>, <62>, <1111>)||2|
|In-process Controls – Bioburden||1|
|Cleaning & Sanitization (Disinfectants and Sporicides)||1|
|Microbial Limits – Nutritional and Dietary Supplements||2|
|Water for Pharmaceutical Purposes||2|
|Environmental Monitoring – Methods||2|
|Environmental Monitoring – Data Trending||1|
|Environmental Monitoring – The EM Master Plan||1|
|Environmental Monitoring – Regulatory Expectations||2|
|Environmental Monitoring – Qualifying the Program||1|
|Contamination Control (for manufacturing support)||2|
|Microbiological Evaluation of Clean Rooms and Other Controlled Environments||2|
|Contamination Control of the Manufacturing Facility||3|
|Basis of the Regulations||1|
|21 CFR 210 & 211 (w/ updates of Dec. 8, 2008)||3|
|21 CFR 610 & 612 2||2|
|GMP – International Perspectives on Microbial Control||3|
|USP Compounding Pharmacy Best Practice (<795>, <797>, <1163>||3|
|History of GMP||2|
|USP and QC Microbiology||3|