Join us during the 2019 ISPE APAC Pharmaceutical Manufacturing Conference as we take a deeper dive into critical areas of the pharmaceutical industry.
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This classroom course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process. This includes a discussion of the FDA Systems Based Approach to inspections (Compliance Document 7356-002). In addition, participants will investigate the science behind the requirements, the people side of GMP, the challenge of defending products against contamination, how to consistently build quality into products, and how to personally audit for GMP compliance and performance. The course will conclude with a discussion on the basic GMP requirements related to facility and equipment controls.
Participants can expect open class discussions, sample problems, and an examination of the text of the regulation CFR 21, Parts 210 and 211 and/or the EU GMP guidelines. Throughout the course, we will emphasize positioning GMP as a tool for successfully coordinating, controlling, and improving quality, and developing regulatory control strategies. GMP will be presented as an opportunity to integrate product quality and regulatory compliance with performance. The course will provide all participants with the confidence to apply GMP to their specific job responsibilities and the comfort level to interact with fellow employees concerning GMP issues, as well as build a foundation for making GMP a lifestyle at their companies.Through hands-on exercises and lectures, you will discuss and explore GMP principles and approaches for active pharmaceutical ingredients (APIs), excipients, and finished pharmaceuticals. Learn easy-to-grasp basics of regulatory requirements, current issues, and trends in the pharmaceutical industry with an emphasis on applying GMP in day-to-day operations.
After understanding the "whys" behind the GMP regulations, participants discuss the history of the GMP regulations, the regulatory process, and the concept of operating in a "state of control," with an emphasis on the regulation of pharmaceutical products.
Carmelo Rosa has a B.S., M.S., Psy.D. His background is in biology and chemistry and holds a doctoral degree as a Clinical Psychologist. He has been with FDA for over 27 years. In May 1990, he started as an Investigator for the Los Angeles district, transferred to Puerto Rico, where he worked for approximately 18 years as a pharmaceutical drug Investigator, Compliance Officer, and member of the FDA foreign drug inspection cadre. He conducted inspections of complex pharmaceutical inspections of sterile, solid dosage, and APIs, as well as other commodities regulated by FDA. He conducted many criminal investigations and inspections that resulted in a regulatory action. In 2008 he transferred to the Washington area, where since, served as Team Leader, Branch Chief, and Director for the Division Drug Quality I in the Center for Drug Evaluation and Research/Office of Compliance/Office of Manufacturing Quality. He works very closely with International Regulatory Authorities. Dr. Rosa is one of two Division Directors responsible for the review of all Official Action Indicated (OAI) inspection reports related to drug manufacturing facilities that may result in a regulatory action.
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Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, firstname.lastname@example.org.