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Distance-Based Training

Use Expert Training from Microbiology Network

The Microbiology Network is a consortium of national experts in GMP, microbiology, GMP, laboratory operations and contamination control that is available to conduct instruction in a variety of topics:

  • Lab QC testing
  • Lab QC GMP
  • Contamination Control
  • Laboratory Investigations
  • Bacterial Endotoxin Testing
  • Microbiology for Manufacturing
  • Objectionable Organisms - Risk Analysis Approach
  • Sterility Assurance

 

Advantages to Distance Training:

  • Save Your Training Budget
    • Economical – train 30 for the cost of 2-4
    • Conduct training in short time frames - an hour a day for a period
    • May be able to charge course under different budget category, preserving limited training budget.
  • Time Saving
    • No travel for your staff, eliminating travel time and uncertainties
    • Customizable training on topics of interest to your facility and staff – no need to sit through irrelevant material waiting for useful information.
  • Everyone stays on-site and accessible if needed
  • You maintain control of the training.

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:

GMP Training

GMP & Contamination Control for Manufacturing

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.

GMP for the Microbiology Lab

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.

  • GMP by 21 CFR 211
    A basic GMP course focusing on laboratory operations and contamination control as described in the cGMPs.  This course also explores USP <1117> "Best Microbiological Laboratory Practices"
  • GMP and Warning Letters
    The basics of GMP in the laboratory and contamination control as illustrated by recent FDA warning letters
  • GMP and Aseptic Manufacturing
    GMP requirements specifically focused on aseptic laboratory controls and the microbiology lab.  This course provides a brief overview of the basics of GMP but focuses on laboratory controls as defined in the FDA aseptic processing guidance.  Environmental monitoring, sterility testing and facility contamination control requirements are stressed.
  • GMP and Non-sterile Manufacturing
    GMP requirements specifically focused on aseptic laboratory controls and the microbiology lab.  This course provides a brief overview of the basics of GMP but focuses on laboratory controls.  The draft USP <1115> "Bioburden Control of Non-sterile Drug Substances and Products" and FDA expectations for absence of "objectionable" organisms are stressed.
  • GMP - Pharma, Cosmetics and Dietary Supplements
    A course comparing the laboratory and contamination control requirements of 21 CFR 211, 21 CFR 111, teh CTFA Cosmetics GMPs and the recently issued FDA GMP for Cosmetics guideline.
  • GMP - Preparation for the Audit
    GMP from the perspective of the inspector.  A good choice for those familiar with the fundamentals of CGMP and who are preparing either to be audited or to audit a contract facility.  This course is useful for either the QC Laboratory or the CMO facility concerned with contamination control.
  • The History of GMP
    GMP is not a series of rules that arose full blown from the FDA's twisted need to impose control.  It is, rather, the lessons learned from errors in the past and the best compromise corrective actions for those unfortumate events.  An appreciation of the background to today's CGMP provides an appreciation for its importance.

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.

Manufacturing Support

Contamination Control for Manufacturing Management

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.

Contamination Control for Manufacturing Personnel

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

QA/QC Microbiology

Auditing the Microbiology Lab

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.

Investigations of Microbiological Data Deviations

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.

Rapid Microbiological Methods

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.

Microbiological Aspects of Sterile USP Articles

This course covers the basics of sterilization, aseptic processing and environmental monitoring/control for sterile products.

Microbiological Aspects of Nonsterile USP Articles

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.”

Microbial Identification in Environmental Monitoring

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.

Understanding the Harmonized Microbial Limits Tests

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.

Compendial Chapters for the Microbiologist

A 3-hour review of USP chapters with relevance to the QC Microbiology Lab. Course focuses on practical methods to achieve compliance.

 

Basic Science

Microbiology for Non-microbiologists

A 2-day course on basic pharmaceutical microbiology for those needing background in the subject (formulators, RA, QC management).

 

Build Your Own Course

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.

Topic

Units

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

Tests/USP

 
Microbial Identification 2
Microbiology Finished Product Test Methods (overview) 1
Antimicrobial Preservatives – Effectiveness 1
Microbial Limits Tests (USP <61>, <62>, <1111>) 2
Sterility Tests 1
In-process Controls – Bioburden 1
Cleaning & Sanitization (Disinfectants and Sporicides) 1
Microbial Limits – Nutritional and Dietary Supplements 2

Manufacturing Support

 
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

GMP

 
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