Pharmaceutical school training courses in Brunswick, ME (public, in-house or online)

This course will provide an orientation and understanding of the Current Good Manufacturing Practice segment of the U.S. Food, Drug, and Cosmetic Act. The course will cover supervisory techniques and practices for complying with the U.S. FDA regulations in packaging, assembly, production and manufacturing. It will provide a practical application of the cGMP on the operating level. Actual experiences and case studies will be included. Ample time will be given to the specific problems of participa...

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This course will introduce you to Current Good Manufacturing Practice (cGMP) in the pharmaceutical and allied industries. Topics covered will include not only the legal requirements for cGMP in the Federal Food, Drug, and Cosmetic Act but, primarily, the practical how-to of purchasing, manufacturing, packaging, labeling and QA/QC, as well as training production personnel in cGMP. The faculty consists of individuals with long and distinguished experience in the field. Throughout this course, the ...

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This three-day course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas:

1. How to develop a pilot process suitable for scale-up to commercial production.

2. Factors to consider during scale-up and technology transfer to take a product from formulation development to the production floor.

The course will review topics su...

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The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management, should be responsible for in ass...

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This course will provide a basic understanding of the technology transfer of analytical methods, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting the transfer within and outside a company. Topics will include transfer of technology to/from international sites as well as to/from third parties. Regulatory requirements and recommended approaches will be dis...

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