Vectech Pharmaceutical Consultants In-house Training Programs
Why spend your training budget in uncertain travel expenses? Rather than send a few select people to training off-site, bring the training in-house!
Vectech Pharmaceutical Consultants can provide extensive training, provided by Ph.D. level experts with decades of experience in the pharmaceutical, personal products and medical devise industries. These courses are provided in your facility to maximize your training dollars. Our training is presented by recognized experts:
David Porter, Ph.D. and Scott Sutton, Ph.D
All courses can be modified to meet specific requirements for your facility. Let us provide training in the following critical areas:
GMP Training
GMP for the Manufacturing Operator;
A 3-day intensive course providing GMP training tailored specifically to the needs of manufacturing line operators. 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 regs, 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.
Manufacturing Support
Microbiology for Manufacturing Management;
This day-long course on pharmaceutical microbiology 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.
Microbiology 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.
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).
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.
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.
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.
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>.
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.
Toxicology
USP Toxicological Testing Chapters and Biocompatibility;
This course examines in vitro and animal testing requirements for toxicology studies and biocompatibility.
For information on scheduling a Vectech Training Program click on the 'more information' button at the bottom of this page.
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