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 performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product

Date : 7th August 2017 to 8th August 2017

Place : Australia, Sydney

Website :https://www.eventbrite.com/e/systematic-operating-procedures-sops-whats-really-required-com-tickets-33511060484?aff=NDT

Contact Person:Paula Edwards

Description:

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 performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product

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 performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product will be held in Sydney,Australia on date 2017-08-08

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Deadline for abstracts/proposals : 1st August 2017

Keynote Speakers : Peggy J. Berry MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official) Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was res

Conference Highlights :This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance: Directors Managers Supervisors Auditors Regulatory operations Clinical investigators, site management and contracting personnel Clinical operations Project managers Data management Medical writers Compliance officers Anyone required to create SOPs for their job function in a regulated industry

Venue :Sydney, NSW, 2000, Australia

Check the event website for more details.