Advantages to in-house 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 & 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
GMP training tailored specifically to the needs of microbiology. Course covers basic GMP, USP chapter <1117>, 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. This course is suitable for the QC lab or the contract testing facility and may serve as the annual GMP training course.
Approach to GMP
These “GMP” courses can be approached 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 (ie separated into functional topic and referenced against guidance documents). This is your choice.
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.
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
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.
USP Toxicological Testing Chapters and Biocompatibility
This course examines in vitro and animal testing requirements for toxicology studies and biocompatibility.
Microbiology for Non-microbiologists
A 2-day course on basic pharmaceutical microbiology for those needing background in the subject (formulators, RA, QC management).
Basic Statistics for Microbiologists
1 day course on fundamental statistics as it relates to the microbiology function. Extremely useful in developing strategies for ISO 17025 accreditation or in developing protocols for validation of alternative microbiological methods.
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.