The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, device, cosmetics, pharmaceutical and agrochemicals industries, whose job function is related to drug/biologic/device discovery, development, and/or manufacturing. All participants will gain a fundamental understanding of the basis of cGMP regulations, and the necessity of rigorously implementing them in daily operations. Special focus is given to the monitoring of...

This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus is placed on basic regulation and the FDA’s supplemental guidelines. Among the topics to be discussed are: the context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general qualit...

The course is designed for management and professional staff involved in – or interested in – quality assurance (QA) and quality control (QC) support for biologics and biopharmaceuticals. Curriculum highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, testing and release of these products.

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address i...

This two-day course is designed for those who manage, audit, or oversee manufacturing of OTC drug products, and for cosmetic manufacturers with OTC drug products (no dosage) performing their operation under a drug cGMP environment. The course will cover regulatory expectations as contained in U.S. and International guidelines. It will prepare attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps, and execute a plan to achieve comp...

This course will give participants the background and history of the Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Additionally, course content will include preparing for FDA meetings and discuss all the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), non-clinical and clinical areas will be covered. The Common Technical Document (CTD) formatt...

This two-day course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues, but is valuable to anyone looking for a refresher or a means to stay current with regulatory agency thinking. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; ho...

This intensive one-week program presents the principles and practice of industrial hygiene and its basis in science, engineering, and medicine. Participants explore how to use key concepts and principles to identify potential workplace health hazards, select methods for the assessment of exposures to hazards, evaluate the consequences of excessive exposure, and institute techniques for prevention and control of occupational disease. Upon completion of this Harvard program, participants wil...