CfPA

CfPA


Analytical Methods Validation for FDA Compliance

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 re...
CfPA

Auditing for GMP Compliance

Who Should Attend? This overview, practical course is designed for those auditors who have recently been involved or expect to be involved in internal or external GMP audits The program will benefit individuals in the pharmaceutical, medical device and related industries like diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations. The course c...
CfPA

Biopharmaceutical Analytics: Method Development

This intensive, 2-day course will teach participants how to develop an array of different analytical methods used in the Biopharmaceutical Industry. Troubleshooting issues during and after development will be discussed for each method as well as practical approaches to strengthening the methods robustness. This accredited course also includes information on how the methods should be used to supp...
CfPA

Biopharmaceutical Analytics: Regulations and Validations

This 2-day accredited training will begin with teaching basic regulations to build a foundation of how a compliant lab and strong systems should be built. The course will then examine methods and attributes that need to be in place prior to qualification and validation activities. Once the stage is set, method qualification and validation will be the main topic of the course. Additional topics w...
CfPA

Crystallization of Organic Compounds

Crystallization of organic compounds is a mean widely used for isolation of active ingredients with desired quality attributes, in pharmaceutical, food, fine chemical and cosmetics industries. It is commonly challenged by both technical complexity and practical constrains. This 2-day, intensive course provides a practical training on crystallization of organic compounds, in light of both fundame...
CfPA

Drug Product Stability and Shelf-Life

Who Should Attend? This course contains in-depth coverage of the science and practice of drug stability, shelf-life and is designed to benefit the following personnel: • QC/QA Managers/Supervisors • Product Stability Managers • Manufacturing Personnel • Research & Product Development Scientists and Managers • Regulatory Personnel • Pharmaceutical Consultants C...
CfPA

Establishing Strategic Global Supply Chain Practices for the Life Science Industry

Life science organizations today are focusing on strategic growth, but equally focusing on supply chain excellence and robustness in order to ensure their viability and global reach. This 2-day course will address key global issues with respect to optimized global supply chain and strategies. Discussions will include the key strategies to be employed which ultimately yield improvements to the or...
CfPA

GLP and Quality Assurance: Developing a GLP Compliant QA Program

Who Should Attend? The participants in this course will already know the basics of GLP. The course is designed for those who wish to master how to implement and maintain a GLP QA function. The course explores quality issues within preclinical GLP and provides an opportunity for experienced personnel to update their competencies. Participants may come from: • Life-Science Industries ...
CfPA

GLP and Quality Assurance: Developing a GLP Compliant QA Program

This 2-day intensive course will explore the activities of a Quality Assurance department when auditing or inspecting studies and facilities for GLP compliance. All aspects of QA work will be discussed including; the preparation of planning documents, review of protocols and SOPs, inspection of facilities and processes, performance of inspections of on-going phases and the audit of final reports...
CfPA

GLP Study Director

Who Should Attend? This course is designed for those who already have some experience in managing GLP studies; those who wish to extend their role to study direction and their competence in study management, particularly in the complex multi-site environment. The course will benefit the following individuals: • Existing Study Directors who wish to upgrade their competence in a mul...
CfPA

Good Laboratory Practices (GLP)

The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various pro...
CfPA

Good Laboratory Practices (GLP)

The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various pro...
CfPA

Granulation, Tabletting and Capsule Technology

The main aim of this course is to review the science relating to tabletted and encapsulated pharmaceutical products. The course begins with a consideration of raw material testing and the basic aspects of powder and granulation technology, progresses through formulation of solid dosage forms to manufacturing processes and equipment including scaleup and technology transfer. The program concludes...
CfPA

Human Factors and Medical Devices

This 90-minute, accredited training course will explain the definition of a medical device and differentiate it from a drug. The FDA device classifications which are based on the level of control necessary to ensure safety and effectiveness and reduce risk or potential harm to the user will be addressed. In addition, a thorough explanation of the US FDA regulations and pathways for devices and c...
CfPA

Hydrocolloids: Gums and Starches

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 ...
CfPA

IQ, OQ, PQ

The installation/operational/performance qualification/ verification of equipment, systems, facilities and processes for pharmaceutical sterile, oral solid dosage biologics, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated and maintained within design specifications and facilities must be accepted as fit for use, wh...
CfPA

OTC Stability Program for FDA Compliance

Who Should Attend? This course is intended for individuals who have the responsibility for establishing the stability of Over-the-Counter (OTC) drug products. This course will benefit individuals in: • R&D • QA/QC • Technical Operations • Contract Laboratories RAPS - Regulatory Affairs Professional Society This course has been pre-approved by RAPS as eligible for up t...
CfPA

Pharmaceutical Technology Transfer and Post-Approval Changes

This 3-day intensive, accredited 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 techn...
CfPA

Powder Mixing Technology

The course presents the principles and techniques of mixing free-flowing or cohesive powders. Selection of suitable industrial equipment for particular mixing duties will be discussed analyzing mixer performance in terms of process advantages, mixture quality and the flexibility of the mixer for multi-product manufacture. Other topics to be covered include powder sampling techniques, a practi...
CfPA

Processing of cGMP Controlled Raw Materials

cGMP Controlled Raw Materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is a very critical part that ensures drug product quality, purity and potency. Drug product manufacturers must have a defined procedure that clearly shows ho...
CfPA

Qualification and Management of CMO’s

Outsourcing operations to CMO’s has become a critical segment of nearly every pharmaceutical company’s operational strategy, yet few clients or contractors achieve the envisioned expectations of these important relationships. The course examines the root causes of these issues which are much broader and deeper than technical capabilities. This practical course outlines both the strategic ...
CfPA

Regulatory Compliance for the Personal Care Products Industry

This 2-day intensive course will provide an in depth overview of the regulatory requirements for personal care products in the United States and the European Union, including additional requirements in the states. It will review the regulatory bodies, enforcement tools and the relevant legislation and guidance to inform regulatory compliance. This will include key agencies having jurisdiction...
CfPA

Starch: Chemistry, Properties and Applications

This course covers the fundamental structure, chemistry, functional properties of starches and their utilization in food applications. The course also reviews the various types of starches and factors that should be considered when choosing and using starches. The application of starches in many food systems is presented in depth. There will be a demonstration of food starches. The most current ...
CfPA

Strategies in Human Error Reduction

This 2 day highly interactive workshop provides significant insight into how our brains work, how we learn, why we make mistakes, and what can be done to minimize future errors. This course will prepare participants to effectively analyze errors and significantly reduce future mistakes by using the proven Six Sigma DMAIC (Define, Measure, Analyze, Improve, and Control) methodology and practical ...
CfPA

Sulfate-Free Surfactants

Surfactants play a vital role in the properties and performance of personal care and cosmetic products. Recently concerns have been expressed about the use of sulfate containing surfactants in cosmetics. The reasons for this are not completely clear. In this 90-minute accredited training, we examine these concerns. We will discuss alternative surfactants and formulations which overcome these dif...
CfPA

Sunscreens: Science, Technology and Product Development

Who Should Attend? This course is designed for professionals in the personal care, cosmetic and pharmaceutical industries who are engaged in sunscreen product development, including those in: • Research & Development • Technology • Marketing & Technical Sales • Regulatory Affairs • QA & QC • Business Decision Making • Formulation & Product Development Cou...
CfPA

Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

Who Should Attend? This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others: • Top Management • Quality Assurance/Control • Regulatory Affairs • Auditing • Engineering • Research & Development • Quality Systems Management • Documentation Management ...
CfPA

Suspensions and Emulsions in Pharmaceuticals and Food

This course is designed to provide a set of theoretical and practical tools for those interested in working with dispersed phases and predicting and understanding their sometimes complex behavior. The participant will learn to use the materials and processes needed to create dispersed-phase products, and to effectively solve problems arising during development. Troubleshooting existing commercia...
CfPA

Suspensions and Emulsions in Pharmaceuticals and Food

This course is designed to provide a set of theoretical and practical tools for those interested in working with dispersed phases and predicting and understanding their sometimes complex behavior. The participant will learn to use the materials and processes needed to create dispersed-phase products, and to effectively solve problems arising during development. Troubleshooting existing commercia...
CfPA

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