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Brunswick, United States

School: The Center for Professional Advancement

cGMP Auditing - Strategies for Compliance
Course Format: Classroom
This practical, introductory course was designed to provide a mechanism for those interested in understanding the basic requirements for auditing in the pharmaceutical and related industries. The course presents an introduction to the evolutionary process of FDA regulations and describes in detail the latest FDA initiatives in the inspection process. It provides a road map for auditors in se...
 

Preparing for and Surviving an FDA Inspection
Course Format: Classroom
This course provides a background and understanding of the role played by the Agency, it¡¯s administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques (QSIT) app...
 

Hair Product Development
Course Format: Classroom
This course provides a review of the main marketing trends in hair care, followed by an analysis of the fundamental properties of human hair as related to cosmetic treatments. A thorough review of the foremost raw materials presently used in the industry will be discussed so that the formulators and marketing professionals will quickly become familiar with the products, properties and raw mater...
 

Clinical Protocols
Course Format: Classroom
Achieving a successful clinical program is based on collecting and evaluating precise safety and efficacy data that will form the basis of information for product approvals by global regulatory agencies. Clinical protocol development is key for product approvals that come under the jurisdiction of INDs, NDAs, BLAs, ANDAs, and CTDs. The clinical process necessary to write protocols that will ...
 

Regulatory Compliance for the Personal Care Products Industry
Course Format: Classroom
This course will provide an in-depth overview of the regulatory requirements for personal care products in the United States and the European Union and will highlight their similarities and differences. It is designed to address the questions of regulatory compliance detailing the current regulations and enforcement tools that control the marketing and promotion of cosmetics and OTC personal ca...
 

Cosmetic Product Formulation
Course Format: Classroom
This course will review the methodologies used to develop the major types of cosmetic and toiletries products. Idea generation, formulation development, manufacturing considerations, and stability testing will be discussed for each product type. The basis in the development of stable emulsions will also be discussed. Among the product types to be reviewed will be: creams, lotions, hair products...
 

Pharmaceutical cGMPs and FDA Inspections
Course Format: Classroom
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...
 

Laboratory Control Systems
Course Format: Classroom
Laboratory Control has been the largest identifiable area of cGMP observations of non-compliance during FDA inspections for the past decade. Recently the FDA changed its inspectional technique to focus on systems. The emphasis of this seminar will be the Laboratory Control System identified in the FDA Systems Inspection Program and the relationship of the Laboratory Control System components to...
 

Skin Product Development
Course Format: Classroom
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, i.e., pharmaceutics. The understanding of formulation¡¯s physical properties, ways ...
 

Pharmaceutical Process Development
Course Format: Classroom
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 produc...
 

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