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

Lyophilization Technology

This course is designed to provide participants with an up-todate understanding of the theory and practice of lyophilization. Freeze-drying (lyophilization) will be presented and explained in physical, physicochemical, biochemical and engineering terms. Theory and practice will be interrelated and biotechnological and pharmaceutical applications will be emphasized. Participants should acquire a......
 

Good Distribution Practices is based on Article 10 of Directive 92/25/EEC of the Board of the European Community governing the wholesale distribution of drugs for human consumption. The directive¡¯s objective is to guarantee control of the entire distribution chain, from the point of manufacture or import to the point of being sold to the public. Drug distributions comply with the principles ......
 

Pharmaceuticals are, by and large, made via batch processes. Sensing controlling and optimizing these unit operations requires instruments that deliver highly specific and definitive information. At-line and on-line devices may serve equally well. Successful deployment may require information at the expense of data. This course provides guidelines for sensor selection and use. Module 1: ......
 

Complaint 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 essential requirements of a Complaint System including setting-up, operating, and managing the system for today¡¯s FDA regulated industry environment. Further, this course pro......
 

This course is designed for practicing food scientists and technologists who wish to develop a pragmatic knowledge of hydrocolloid technology and its utilization in food product development. Although pharmaceutical and cosmetic applications are not specifically covered in this course, the principles presented are easily extended to applications in those two fields. Almost all processed foods......
 

This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and European regulatory bodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICH requirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stabilit......
 

Water is the single largest volume ingredient used in biopharmaceutical manufacturing, and permeates every aspect of biopharmaceutical operations. The use of water, and steam derived from water, constitutes a major operational and quality issue in the industry on a worldwide basis. This course will provide a much needed overview of water systems, their design, operation, maintenance, and valida......
 

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 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 co......
 

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......
 

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 prod......
 

This course provides a comprehensive explanation of the nonclinical development of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and pr......
 

The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in, toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management, the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various procedures......
 

This course will include discussion on topics such as container/closure integrity testing, product stability studies, engineering heat penetration and distribution studies, container thermal mapping, and environment control programs. In addition to an overview of moist heat sterilization, and FDA requirements, the attendees will participate in the resolution of proposed case studies, and perfor......
 

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 topica......
 

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process and have separately expanded method validation r......
 

This course is designed to provide an overview of modern near infrared spectroscopy for those who are inexperienced in the field. In addition, it should reinforce the lessons learned in instrument manufacturers¡¯ training courses or from instruction manuals from specified manufacturers, and will add new perspectives and practical information for the more experienced user. This course will includ......
 

The U.S. Court of Appeals for the Federal Circuit is the focal point for the legal criteria by which US patents are enforced. The Court¡¯s rulings on recent multi-million dollar patent infringement awards illustrate how important it is for the business manager to understand how the patent system works. With the great increase in the cost of technology development, and the rapidity of technica......
 

The design of topically applied formulation combines scientific knowledge in physics, chemistry, engineering and biochemistry and requires imagination and artistic skills. Throughout the design, one must become familiar with the fundamentals of skin structure, its pharmacology and possible delivery approaches. The understanding of formulation¡¯s physical properties, ways of measuring these pr......
 

Equipment Qualification has 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-bystep guide to planning and preparing for equipment qualification and includes a discussion of how to write qualification protocols, handle deviations, report qualification reports and ¡°mai......
 

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