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Brunswick, United States

School: The Center for Professional Advancement

Sulfonation and Sulfation
Course Format: Classroom
Sulfonation and sulfation processes are widely used in industry to make products such as water-soluble detergents, emulsifiers and demulsifiers, penetrating and solubilizing agents, lubricating oil additives and rust inhibitors. These materials are used in household and commercial detergent applications, food processing, dyes, cosmetics manufacturing, metal treating compounds, high detergent an...
 

Excipient GMPs
Course Format: Classroom
This course will cover the regulatory, quality, and manufacturing issues involved in providing chemicals for use as excipients (inactive ingredients) in the manufacture of drug products. You will learn about the regulation of chemicals sold for use as excipients by the FDA, the expectations of the pharmaceutical industry, and excipient quality system requirements (GMP). There will also be topic...
 

Current Good Manufacturing Practice (cGMP) for Purchasing
Course Format: Classroom
Purchasing is a vital part of the operations used to produce pharmaceuticals for either commercial or R&D purposes including clinical supplies. Therefore, from an FDA viewpoint, the purchasing function must, where applicable, conform with the cGMPs for drugs. Some of this conformance forms part of the daily activities of purchasing such as the need to order only from approved suppliers. Other a...
 

ICH Q10: Pharmaceutical Quality System
Course Format: Classroom
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 elem...
 

IQ, OQ, PQ
Course Format: Classroom
The installation/operational/performance qualification of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated, and maintained within design specifications, while processes must be shown to be reliable, all of which to assure t...
 

ICH-Q7A
Course Format: Classroom
It is essential that API production facilities operating under local regulatory authorities in different regions consistently produce the same API that meets the quality attributes and characteristics it is intended to have. An Expert Working Group developed the ICH-Q7A document as a single standard that all suppliers should apply to production of APIs used in human products manufactured in any...
 

Pharmaceutical Technology Transfer
Course Format: Classroom
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...
 

Tablet Production for Operators and Supervisors
Course Format: Classroom
This course provides an orientation and understanding of bulk tablet production for process operators and first-line supervisors. The course begins with the basic aspects of tablet formulating and the unit operations necessary to produce production quantities. All aspects of granulating, compressing, coating, printing, cleaning and documenting will be covered. The application of cGMP, as applie...
 

Preparation, Packaging and Labeling of Clinical Trial Materials
Course Format: Classroom
The aim of this comprehensive course is to provide an introduction to the many details that must be considered in the design, preparation, packaging, labeling and distribution of clinical trial materials in support of adequate and wellcontrolled clinical studies. Emphasis will be given to practical examples of procedures, components, and regulatory requirements needed to provide acceptable inve...
 

Packaging of Pharmaceuticals
Course Format: Classroom
This intensive course provides the participants with the knowledge of how packaging for all types of pharmaceuticals (ethical, OTC, veterinary medicines) and other related products are developed, manufactured, tested, filled, transported, stored and used. Emphasis will be placed on the characteristics of all commonly used packaging materials which can influence the packed product; protection, c...
 

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