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Brunswick, United States

School: The Center for Professional Advancement

Root Cause Investigation for CAPA
Course Format: Classroom
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...
 

ADME: Absorption, Distribution, Metabolism and Elimination
Course Format: Classroom
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...
 

Non-Clinical Drug Safety Evaluation and Drug Development
Course Format: Classroom
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...
 

Process Validation for the Pharmaceutical and Medical Device Industry
Course Format: Classroom
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...
 

Microbiological Control and Validation
Course Format: Classroom
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...
 

Drug Product Stability and Shelf-Life
Course Format: Classroom
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...
 

Analytical Methods Validation for FDA Compliance
Course Format: Classroom
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...
 

Documentation Management and Control
Course Format: Classroom
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...
 

Microencapsulation and Particle Coating
Course Format: Classroom
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...
 

Gums and Hydrocolloids
Course Format: Classroom
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...
 

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