Regulatory compliance 2018 - 3-Hour Virtual Seminar on Writing Effective SOPs

Overview
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real world. An SOP or Standard Operating Procedure is used to ensure business processes are well thought through, that each task in a process is performed the same way every time, and important data is recorded, along with errors or deviations so corrective action can be taken. Standard operating procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce.
Managers and advisers benefit from consistent work performance and predictable results. Workers benefit from increased confidence and a clear sense of achievement. Producing a high-quality product at a profit depends on the consistent operation of all systems within the company.
SOPs describe the basic systems shared by all company employees. Company success depends on how well these systems work together to produce large volumes of high-quality product that is safe and effective for patients and consumers.
Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization.
Areas Covered in the Session
What is an SOP
When to have an SOP
Who writes SOPs
What the SOP should say
The SOP template
SOP review and Approval
Active SOP maintenance
Training the staff on SOPs
Who Will Benefit
VP of IT
Director of IT
Quality Managers
Project Managers (for CSV / IT)
Validation Specialists
Database Administrators
System Administrators
Directors /Senior Directors of Discovery
Directors /Senior Directors of Development
Directors /Senior Directors of Commercialization
Document Managers
Training Managers
Regulators
Vendors
Suppliers
Outsource Service Providers
Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA http://www1.diahome.org/~/media/4FA562336EBD46C58C... on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/... includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144....
Event link: https://www.traininng.com/webinar/3-hour-virtual-s...
Contact Details:
Joseph Wilcox
Traininng.com LLC
traininngdotcom-AT-gmail.com
Phone:
US: (510) 962-8903
Zurich: +41 - 43 434 80 33
https://www.traininng.com