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This course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory ex... more information   send enquiry

Introductory Methods. This part of the course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical ... more information   send enquiry

This two-day course has been designed as an introductory course on cGMP for pharmaceutical, biotech and medical device personnel. It will assist those who are responsible for compliance with FDA cGMP... more information   send enquiry

Because of its comprehensive overview, this course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers... more information   send enquiry

This course provides a background and understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. It will take you step-by-step through the DMF preparation p... more information   send enquiry

If you didn’t write it down, it didn’t happen! This is the position of FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from dis... more information   send enquiry

Who Should Attend This course is directed toward, and geared for those who assemble, supervise, or manage the preparation and submission of Abbreviated New Drug Applications (ANDAs). The course is su... more information   send enquiry

This course is specifically designed for Clinical Research Monitors (CRMs) and Clinical Research Auditors (CRAs) and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Cl... more information   send enquiry

The course is designed for all Scientists (managerial and laboratory) whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings w... more information   send enquiry

Upon completion of this course you will have gained a thorough understanding of FDA expectations for the activities required to deal with OOS results in a compliant manner. You will have the backgroun... more information   send enquiry

This course is directed toward, and geared for persons whose responsibilities include compliance with cGMP regulations for biopharmaceuticals and biologics. No prior regulatory experienced is assumed,... more information   send enquiry

High-quality medical writing has a multi-million dollar impact on a company’s financial performance. Good medical writing can lead to an optimal product label, allowing successful product promotions ... more information   send enquiry

Learning Objectives After completion of this course the attendee will have a strong understanding of the principles and practices of Project Management, including how to: • Work with the sponsor to ... more information   send enquiry

This course will teach all attendees how to develop essential CMC tactics and techniques in preparation of the CMC Section of the IND and NDA. It will also provide a detailed overview of CMC require... more information   send enquiry

This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on both the regulation and FDA’s supplemental guidel... more information   send enquiry

This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied in designing stability programs from the early stages of product development all the way to app... more information   send enquiry

This course is directed toward, and geared for Analytical Development, Quality Control, Stability, Formulation and pre-Formulation professionals involved in developing and running stability tests for ... more information   send enquiry

While the birth of ICH took place in 1990, it was not until 2000 that the 3 major regulatory agencies (FDA, EMEA, JMHWL) signed off on the Common Technical Document (CTD) format. ICH M4 was thus intr... more information   send enquiry

The course strategy is to introduce and detail the basic issues and questions of study design and analysis that one should consider when reading published journal articles. This course is designed t... more information   send enquiry

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: “If you didn’t write it down, it didn’t happen,” and w... more information   send enquiry