The Center for Professional Advancement
New Brunswick, New Jersey, United States
http://www.cfpa.com

Generic Drug Approvals

When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Waxman-Hatch Act"), it enabled the pharmaceutical industry to seek approval via an ANDA of generic versions of the vast majority of drugs approved by FDA since 1962. New, complex requirements were imposed on persons seeking FDA approval of these generic drugs. Congress also created incentives......
 

When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Waxman-Hatch Act"), it enabled the pharmaceutical industry to seek approval via an ANDA of generic versions of the vast majority of drugs approved by FDA since 1962. New, complex requirements were imposed on persons seeking FDA approval of these generic drugs. Congress also created incentives......
 

Good Clinical Practice (GCP) procedures entail the obligations of Investigators, Sponsors, and Monitors and their staff in the conduct and legal aspects of clinical research in the process of new product development. This course will emphasize the specific responsibilities and obligations of all individuals involved in clinical research for international New Drug Applications. Selection of inve......
 

The FDA is using a systems approach for both its domestic and foreign drug cGMP inspections. The approach consists of classifying a firm¡¯s operations into six types of systems: (1) The Quality System (2) Facilities & Equipment System (3) Materials System (4) Production System (5) Packaging & Labeling System and (6) Laboratory Control System. The systems inspected depend upon the purpose of the ......
 

The course will present a review of the activities that will occur in the process of setting specifications for APIs made by synthesis or conventional fermentation. Critical specification issues for drug substances and drug products will be reviewed, specifically focusing on the interactions and dialogue necessary between analytical and pharmaceutical/ chemical groups during the development of ......
 

The program will provide an introduction to various drug delivery routes and describe the technologies that are used in each of these routes. Emphasis will be placed on methods developed in recent history rather than the older techniques of pharmaceutical compounding and also on proven technologies with results and actual applications rather than just research in this field. Each lecturer will ......
 

This two-day course will give a comprehensive overview of the regulatory requirements, design, conduct and analysis of FIM (first in man) studies of new drugs, biologics and medical devices in human beings. The participant will come away knowing what must be done and what cannot be done for and in such studies and how these fit into the development process. This course will benefit those in ......
 

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 ......
 

Most organizations have procedures for implementing corrective and preventive actions, but many do not have an effective methodology to actually investigate to find the root cause. As a result the investigation is often careless, unsuccessful, and costly. Root Cause Investigation for CAPA is a proven methodology to investigate and identify the root cause when there has been a shift in the perfo......
 

The course will provide participants with an understanding of the principals and fundamentals for absorption, distribution, metabolism, and the elimination (ADME) of pharmaceutical chemicals. The actual dose of a drug that ultimately reaches the target tissues and exerts pharmacologic or toxicologic effects is highly dependent on the kinetics of drug absorption and disposition in the body. Many......
 

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......
 

Validation of manufacturing processes in the cGMP environment is recognized by the medical manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. This course will give the attendee an overview and understanding of the validation process, how to organize it and carry out process validations, key areas to look for during an audit, and assist managers in overall plann......
 

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......
 

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......
 

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......
 

FDA regulations such as Good Manufacturing Practice (GMP) for drugs and medical devices, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), as well as quality system standards like ISO 9000, require that documentation, such as standard operating procedures, plans and various types of records, be in place. These regulations, however, do not provide any guidelines to the industry on ho......
 

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......
 

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 review the current regulations and expectations for the use of risk management processes and methods in the life cycle of medical devices. We will discuss the use of the ISO 14971:2000 standard and FDA¡¯s guidance documents on Human Factors Engineering to provide a clear understanding of what techniques to use and when they should be implemented. Practical workshop activities wi......
 

In today¡¯s corporate environment of limited available resources and multiple projects being performed simultaneously and competing for the necessary resources, project management and the requisite project planning is increasingly important. The effective management of projects is the first line of control in the overall management of an organization. This basic course covers the essential knowl......
 

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