GMPs

Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities. This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology. Supporting Documents:....

Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk activities and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market. This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies....

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. This classroom course is designed to help participants understand the GMPs as they relate to....

You may also be interested in our training course on Auditing for Medical Devices . Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to....

The highly interactive classroom course uses extensive exercises to provide an intense examination and interpretation of the cGMP regulations with special emphasis on applying the "right dose" of GMP to various situations to assure that methods, facilities, and controls are used for the manufacture processing, packing, or holding of drug products to meet requirements for safety, identity, strength, quality, and purity. The regulation will be divided into six elements: materials, buildings, equipment, records, procedures, and people. Participants will focus on compliance strategies for interpreting the controls needed to continuously operate in a state-of-control, validation, cleaning, and training interpretations will be....