Major Farma Services
A full-service and solutions provider for the Pharmaceutical Industry

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Training Courses:

If you are interested in taking any of the online courses, please contact us for pricing and access information.  If interested, we can also provide a free one day access to the course for evaluation purposes.

Using Microsoft Word XP for Batch Record Preparation (Online Training)

This easy to follow and intuitive online training explores Microsoft Word features that simplify the process of creating and editing complex batch records with references to other parts of the document or steps.  Adding and/or removing manufacturing steps to your batch record will never be easier once you take this course.  You must have a username and password in order to take this training.

How to Investigate and Document Manufacturing Deviations

This online training teaches a structured approach to investigate manufacturing deviations and provides an easy to follow template for documenting the results of the investigation.  This structured approach can complement your company's existing procedures for handling deviations in order to achieve a consistent "look and feel" that an inspector can easily follow during FDA inspections.

ICH Q7A GMP Guidelines for Active Pharmaceutical Ingredients

This two-day course reviews the guidelines posted by the FDA on September 2001, and outlines the fundamental differences between codified GMP regulations 21 CFR Part 210 & 211 and the Q7A Guidelines. The course also covers questions posed by the industry to the expert working group (EWG) that created the guidelines and answers provided by the EWG during a series of workshops sponsored by various organizations including the FDA.

A Practical Approach to Complying with ERES Regulations

This two-day course reviews the basic requirements of 21 CFR Part 11 and provides tools for determining what systems at your facility are covered by this regulation. The tools described cover the range of answering simple common sense questions to enterprise-wide GAP analyses.

Fundamentals of Manufacturing Operations for Chemical Operators

This two and a half day course has been custom designed for operators engaged in the manufacture of active pharmaceutical ingredients (API) and/or intermediates. The course teaches the fundamentals behind process parameters normally involved in API manufacture and a basic review of the different unit operations used in API manufacture such as; reaction, distillation, crystallization, liquid/liquid extraction, drying, milling, and heat exchange.