Pharma arena for auditing , consulting , training & project management .

Pharma arena Training Courses of the second half of 2019 from July To December 2019

Overview CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA / EU-regulated industries like biotech and pharma, since products from these sectors impact public health and safety. Why Computer System Validation? A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.

Involvement of third parties is not limited to manufacturing and packaging. Product development, specialized processing, such as radiation sterilization, testing, and logistics, are examples of supply chain elements that have increasingly become candidates for third-party outsourcing.

The successful design and realization of an FDA-validatable facility does not happen by chance. Early coordination and communication among all parties involved is essential, from process design and scale-up through cGMP layout, FDA pre-construction design review, commissioning, validation, and on-site inspection by regulatory authorities. A complete "Basis of Design" document is necessary to optimize the utilization of scarce resources. Time spent in design optimization in the front-end, well in advance of the "bricks and mortar" stage, will be saved many times over.

Successful cleaning validation ensures that patients are not put at risk due to cross contamination during production. Cleaning validation is recognized as the most important activity as it has a direct effect on patient safety and drug quality. As it has adverse effects, the global regulatory authorities are keeping a close check on pharmaceutical companies.

Despite the high-tech image of pharmaceutical facilities, many of today's manufacturing plants are over 20 years old and have developed in an unstructured manner. Support services will often have been provided individually on a project-by-project basis where, with hindsight, a more holistic approach would have been more cost-effective. Time pressures on new projects may have resulted in new facilities being located in the most convenient position rather than the best location for the overall site development.

The course is designed to address an ever-growing need to audit not only your own operations but those of your suppliers and service providers to ensure compliance with diverse international Good Manufacturing Practice (GMP) and regulatory requirements, as well as ensuring the detail of your own procedures and submissions. The course is based on GMP and auditing the pharmaceutical quality management system .

This program provides practical tools for better managing and motivating Medical Reps. It also highlights the manager’s role in developing his people through coaching and performance management. Moreover, it allows managers to adopt an implementable strategy when preparing their territory action plan.

This course is mandatory for all medical representatives to start their career in a pharmaceutical company, whether having previous experience in other companies or not. It will provide them with the knowledge of the pharmaceutical market, as well as the basic skills & behaviors necessary to perform their job, in addition to using micro marketing principles to profile their customers in order to set call objectives and conduct more professional sales dialogue.

its a demonstrative course for the newly graduates and undergraduates pharmacy students