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Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and ensure compliance for your company.
This intensive accredited training provides the basic principles and practices of Quality Assurance, Quality Management, Quality Control, and use of robust Quality Systems in the pharmaceutical industry. The course is presented in an open, interactive manner, encouraging discussion throughout. The material also applies to the bio/pharmaceutical, diagnostic, and medical device industries.
This introductory course would be beneficial to excipient and API suppliers. Discussions will include the role of quality, major elements of pharmaceutical quality, the impact of management practices, the features of an effective quality organization, quality management throughout the product life cycle, and the role of corporate quality.
This course discusses current quality issues including outsourcing, the evolution of global regulatory approaches, global standards, and the use of such techniques as Risk Management, Quality-by-Design and the Quality System approach.
Upon completion of this course, you will be able to:
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This introductory course will benefit those who need to understand the responsibilities and functions of the Quality Unit in a pharmaceutical firm. Participants will learn how the quality organization impacts all areas of operations and works as a team to help assure the quality of the products. In addition, the course highlights how to maintain compliance to regulations within the pharmaceutical manufacturing arenas and for supplier related materials or finished product.
This course is particularly suitable for chemists, pharmacists, engineers, and administrators working in the following areas:
This course will also benefit personnel who manage these individuals as well as personnel who are suppliers to the industry.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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