The Center for Professional Advancement
Amsterdam, Netherlands
http://www.cfpa.com

ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

This course provides a detailed description of the current European and US regulations for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. With 25 European countries now using the ISO 13485 standard, it is critical to companie......
 

These days it is irresistible for anyone not to relate any particular area of science and technology to Nanotechnology, which refers to materials and structures at the nanoscale, i.e. < 100 nm (one-ten thousands of a millimeter). The impact or more precisely, the potential impact of Nanotechnology across all disciplines has become the subject of study for the majority of academic and industr......
 

This program will provide an up-to-date assessment of available encapsulation techniques. Each lecturer will present the basic chemical and physical principles of their processes, as well as a discussion of specific techniques and applications. The aim of the program is to provide an understanding of the unique advantages and difficulties of each major microencapsulation technique. Emphasis wil......
 

Complaint handling systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry FDA environment and will give you tools for survival. It will provide a step-by-step guide to the setting-up, operation, management and auditing of a complaint system for today¡¯s medical device industry environment. There will be case studies in which various ......
 

Food extrusion has become a very important processing operation. Today, the food extruder is used to produce pasta and other cold formed products, ready-to eat cereals, snacks, pet food, confectionery products, modified starches for soup, baby food and instant foods, beverage bases and texturized vegetable proteins. This course is designed to provide a thorough background in extrusion principle......
 

This course covers the fundamental structure, chemistry, functional properties of starches and their utilization in food applications. The course also reviews the various types of starches and factors that should be considered when choosing and using starches. The application of starches in many food systems is presented in depth. There will be a demonstration of food starches. The most current......
 

This practical, introductory course was designed to provide a mechanism for European auditors to understand the basic requirements for auditing in compliance with Unites States Current Manufacturing Practice for Drugs and Finished Pharmaceuticals and with Quality Systems regulations. The course presents an introduction to the evolutionary process of the regulations and provides a road map for a......
 

The course presents the principles and techniques of mixing free-flowing or cohesive powders. Selection of suitable industrial equipment for particular mixing duties will be discussed analyzing mixer performance in terms of process advantages, mixture quality and the flexibility of the mixer for multi-product manufacture. Other topics to be covered include powder sampling techniques, a pract......
 

This course reviews the current state of the technology associated with pharmaceutical, medical device, active pharmaceutical ingredient, medical component, R&D, and microbiological clean rooms. Regulations and guidelines for the U.S. and E.U. will be covered. The course is conducted in an environment that encourages discussion, questions, input, and debate by the attendees. Case studies of ......
 

This course will provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces. It will address the latest issues, industry practices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analytical methods, residue challenges, grouping strategies and validation protocols. Examples of current indust......
 

This course will present information on microbiological control in manufacturing, laboratory auditing and sterilization. The course will also cover ISO, EP, BP, USP, AAMI and U.S. FDA documents and guidelines. Validation of sterilization processing will be discussed and case studies will be presented. Environmental monitoring programs will be discussed in depth. Design and testing of product pa......
 

The principle aim of this course is to review the science behind tabletted and encapsulated products. The course begins by considering the raw materials, their characteristics, testing and sampling, and progresses through the formulation of solid dosage forms to manufacturing technology, processes and equipment, including scale-up and technology transfer. The program finishes with key aspects o......
 

From both a regulatory and business perspective, firms should partner with their suppliers (both vendors and contract suppliers) to assure that they receive materials and services according to predetermined specifications for quality, quantity and delivery. Some firms limit this activity to some degree of ¡°qualification¡± while others extend it to ¡°certification¡± or to some type of ¡°strategic al......
 

This course will review the methodologies used to develop the major types of cosmetic and toiletries products. Idea generation, formulation development, manufacturing considerations, and stability testing will be discussed for each product type. The basis in the development of stable emulsions will also be discussed. Among the product types to be reviewed will be: creams, lotions, hair products......
 

This course emphasizes the application of emulsion and suspension principles to the solution of practical, technological problems in the preparation and evaluation of pharmaceutical, cosmetic and related personal care products. Throughout the course, the interrelationship of the many specialty areas involved in emulsion and suspension products will be stressed. Newer technologies such as microe......
 

This course provides a comprehensive look at the broad spectrum of color additives that are used in decorative cosmetic products, including standard organic and inorganic pigments as well as pearlescent, fluorescent and surface treated ones. Starting with a discussion of color basics from a physics perspective, it then moves to the selection of colors from the viewpoints of regulations, stabili......
 

This course provides a practical treatment of crystallization technology, presented in light of the many recent advances in the understanding of crystallization processes. Emphasis will be given to the practical problems of crystallizer operation, and a logical way of understanding the potential and limitations of crystallizer performance will be presented. Both organic and inorganic systems wi......
 

This course is designed to bring you up-to-date on the basic principles involved in colloid and interface science, as well as surfactants, and to demonstrate their relevance for solving practical problems. Such problems are encountered in various engineering aspects of formation of dispersions, their longterm physical stability, and the preparation of various systems of paints, inks, agrochemic......
 

This course focuses on the science and principles concerning stability of pharmaceutical, biotechnology and cosmetic products. Kinetic approaches to chemical stability will be covered and the advantages and limitations of accelerated stability testing will be discussed. Degradation by chemical, physical and microbiological factors will be covered. Data analysis and practical aspects of stabilit......
 

This course provides a review of the main marketing trends in hair care, followed by an analysis of the fundamental properties of human hair as related to cosmetic treatments. A thorough review of the foremost raw materials presently used in the industry will be discussed so that the formulators and marketing professionals will quickly become familiar with the products, properties and raw mater......
 

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