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

Hair Product Development

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......
 

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 ......
 

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......
 

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......
 

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 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......
 

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 ......
 

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......
 

Sulfonation and sulfation processes are widely used in industry to make products such as water-soluble detergents, emulsifiers and demulsifiers, penetrating and solubilizing agents, lubricating oil additives and rust inhibitors. These materials are used in household and commercial detergent applications, food processing, dyes, cosmetics manufacturing, metal treating compounds, high detergent an......
 

This course will cover the regulatory, quality, and manufacturing issues involved in providing chemicals for use as excipients (inactive ingredients) in the manufacture of drug products. You will learn about the regulation of chemicals sold for use as excipients by the FDA, the expectations of the pharmaceutical industry, and excipient quality system requirements (GMP). There will also be topic......
 

Purchasing is a vital part of the operations used to produce pharmaceuticals for either commercial or R&D purposes including clinical supplies. Therefore, from an FDA viewpoint, the purchasing function must, where applicable, conform with the cGMPs for drugs. Some of this conformance forms part of the daily activities of purchasing such as the need to order only from approved suppliers. Other a......
 

The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main elem......
 

The installation/operational/performance qualification of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated, and maintained within design specifications, while processes must be shown to be reliable, all of which to assure t......
 

It is essential that API production facilities operating under local regulatory authorities in different regions consistently produce the same API that meets the quality attributes and characteristics it is intended to have. An Expert Working Group developed the ICH-Q7A document as a single standard that all suppliers should apply to production of APIs used in human products manufactured in any......
 

This course will provide a basic understanding of the technology transfer of analytical methods, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting the transfer within and outside a company. Topics will include transfer of technology to/from international......
 

This course provides an orientation and understanding of bulk tablet production for process operators and first-line supervisors. The course begins with the basic aspects of tablet formulating and the unit operations necessary to produce production quantities. All aspects of granulating, compressing, coating, printing, cleaning and documenting will be covered. The application of cGMP, as applie......
 

The aim of this comprehensive 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 acceptable inve......
 

This intensive course provides the participants with the knowledge of how packaging for all types of pharmaceuticals (ethical, OTC, veterinary medicines) and other related products are developed, manufactured, tested, filled, transported, stored and used. Emphasis will be placed on the characteristics of all commonly used packaging materials which can influence the packed product; protection, c......
 

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 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......
 

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