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Brunswick, United States

School: The Center for Professional Advancement

Quality Audits
Course Format: Classroom
Government regulations have both explicit and implicit requirements for an internal audit function in the pharmaceutical and related industries. Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance. The course will deal primarily with auditing techniques which are applicable to any industry or function. Spec...
 

Good Clinical Practices (GCP)
Course Format: Classroom
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...
 

Generic Drug Approvals
Course Format: Classroom
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...
 

Generic Drug Approvals
Course Format: Classroom
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 Practices (GCP)
Course Format: Classroom
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 Quality System
Course Format: Classroom
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 ...
 

Drug Specifications for APIs and Drug Products
Course Format: Classroom
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 ...
 

Drug Delivery Technologies
Course Format: Classroom
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 ...
 

Early Stage Clinical Studies for Drugs and Devices
Course Format: Classroom
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 Procedures for Medical Devices
Course Format: Classroom
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 ...
 

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