Well trained employees are essential for business planning. Integral Solutions is proud to offer a range of regulatory compliance training programs covering the current regulatory requirements in aspects of Computerized Systems Validation in Life science industries, Regulatory Affairs and Submissions and Intellectual Property Rights which proves beneficial to the industry professionals and students aspiring for career in regulated industries in life science sector. All courses can be customized to the need of the students and industry professionals. Fundamental and in depth training seminars are delivered onsite.
Giving students an insight into the practicalities of the pharmaceutical industry where computerized systems are the key work force for the life science industry. We shall provide the students with the basics of the quality management system in the Pharmaceutical industries working in parallel to the business processes.Regulatory Affairs and Submissions
Country wise Regulations and requirements; Types of key regulatory submissions; Regulations in India; Regulatory Submissions to DCGI; Schedule M and its implications in IndiaIntellectual Property Rights
Introduction to IPR; the regulations and treaties governing IPR all over the world; Indian Patent Act 1970 and its amendments; IPR in Pharmaceuticals; patent search; drafting of patent claims and specifications; Indian Patent scenario; Case Studies
Covering various regulations and guidance that lay down specific requirements for the Computerized Systems being used in the regulated environment. The training will gives a detailed insight into the regulations like US FDA 21 CFR Part 11, 210, 211, 820; Therapeutic Goods Associations; EU – Eudralex Volume 4 for Good Manufacturing Practices; ANIVSA; PIC/s guidelines, GAMP guidelinesGAMP 5 and Good Practices Guides
Covering detailed insight into the GAMP 5 guide and its supporting good practice guidesTypes of Computerized Systems and their validation
Covering the types of computerized systems being used in the life sciences sector which need to be validated as per the regulations. We also give you an insight on the Good Validation Practices for these Computerized Systems.