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

Documentation Management and Control

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 course fills the void between the curriculum of a theoretical education and the practical demands of applied process engineering or process-mechanical engineering. It is structured to follow the major responsibilities of a process engineer as a project progresses. Therefore, the course reviews such topics as: in-depth explanation of necessary process documentation emphasizing engineering d......
 

This course will provide an orientation and understanding of the Current Good Manufacturing Practice segment of the U.S. Food, Drug, and Cosmetic Act. The course will cover supervisory techniques and practices for complying with the U.S. FDA regulations in packaging, assembly, production and manufacturing. It will provide a practical application of the cGMP on the operating level. Actual experi......
 

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......
 

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 first four days of the course will deal primarily with auditing techniques which are applicable to any ind......
 

The aim of this course is to give you a full understanding of the LAL test including principles, practice, limitations and regulatory considerations. Endotoxins are recognized as being by far the most significant pyrogen, but they are often poorly understood. LAL testing for the presence of endotoxins is now a well established procedure in the manufacture of products that enter the blood stream......
 

This intensive online course will focus on learning and understanding the major changes occurring in the skin when aging. Topics include: Skin layers- basic structure and properties: Stratum corneum and epidermis; Dermis; Hypodermis Major structural and biochemical changes occurring with skin aging: Stratum corneum, its lipids and pathways for penetration; Epidermis; Dermis- collagen and ......
 

Atomization is an important process used in many industries, including chemical, petrochemical, biochemical, medical, food, paper, combustion, fuels, and agriculture. This course provides an introduction to atomization for engineers, scientists and technologists who are interested in or need to know more about atomization, atomizer design, atomizer specifications and selection for various appli......
 

This course will provide concepts, methods and advice on how to scale-up or translate a process or model to larger sizes. Emphasis throughout the course will be on proper designs, modeling and processing. The importance of the process geometry will be emphasized. The course will cover the different scale-up methods and how to establish viable process objectives. A general scale-up method is ......
 

The intent of this course is to address the three aspects of plant safety system design: Identification of hazards which have the potential to cause or lead to undesirable events as well as quantification of risk associated with those hazards using Layers of Protection Analysis (LOPA). Definition of the process design intent to eliminate, mitigate or safely respond to those hazards Prope......
 

This course is intended for PAT program managers and team members who are pressed for time and the need for rapid decision-making. The course advocates simple-to-master tools that help persons with PAT responsibility proceed without getting bogged down in excess infrastructure. It is recommended for: PAT program managers PAT team leaders Production managers Regulatory affairs personnel......
 

The aim of this comprehensive survey course is to provide an introduction to the many details that must be considered in the design, preparation, packaging, labeling and distribution of clinical trial materials in support of adequate and wellcontrolled clinical studies. Emphasis will be given to practical examples of procedures, components, and regulatory requirements needed to provide acceptab......
 

The initial start-up of any plant, irrespective of size, type, technology or industry, is a unique experience that poses some special problems. Lack of experience in dealing with these problems has frequently resulted in prolonged and costly startups, caused by inadequate preparation for the events of start-up. This course provides guidance for the necessary preparation required to achieve a su......
 

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