Contact Person : Event Manager ; Last Date for the submission of abstract : 01/06/2018; The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements.

Contact Person : Event Manager ; Last Date for the submission of abstract : 03/06/2018; Times have changed, and unfortunately, many businesses are losing clients or are unable to get new clients due to problems with their compliance program or lack of a compliance program.

Contact Person : Event Manager ; Last Date for the submission of abstract : 05/06/2018; This seminar will demonstrate how Covered Entities and Business Associates can comply calmly, confidently and completely with the HIPAA Rules.

Contact Person : Event Manager ; Last Date for the submission of abstract : 05/06/2018; This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

Contact Person : Event Manager ; Last Date for the submission of abstract : 05/06/2018; The course will let you see inside an FDA investigators mind set and what the agency will do when it evaluates what the investigator says and documents.

Contact Person : Event Manager ; Last Date for the submission of abstract : 08/06/2018; Regulatory bodies are placing increased emphasis on risk management, and technology shts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk ma…

Contact Person : Event Manager ; Last Date for the submission of abstract : 10/06/2018; The 2-day seminar explains how to apply statistics to manage risks and veryvalidate processes in R&D, QAQC, and Manufacturing, with examples derived mainly from the medical device designmanufacturing industry.

Contact Person : Event Manager ; Last Date for the submission of abstract : 12/06/2018; Well move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. Well discuss tools and techniques for improvement and how to…

Contact Person : Event Manager ; Last Date for the submission of abstract : 12/06/2018; This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, inv…

Contact Person : Event Manager ; Last Date for the submission of abstract : 12/06/2018; The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved.

Contact Person : Event Manager ; Last Date for the submission of abstract : 12/06/2018; Team development, the most critical and overlooked component of any project, will be discussed in depth emphasizing the importance of the human element in the execution of any project.

Contact Person : Event Manager ; Last Date for the submission of abstract : 12/06/2018; One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performe…

Contact Person : Event Manager ; Last Date for the submission of abstract : 17/06/2018; The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

Contact Person : Event Manager ; Last Date for the submission of abstract : 22/06/2018; Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.