Webinar Under way - Key Factors up Write an Effective Standard Operating Procedure (SATURATE) and Work Instructi
This webinar will prescribe the participator on how to write, integrate, and maintain SOPs and drench hands in a way that will ensure compliance in a way that is docked, reproducible and cheap to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help segment operations way in addition so as to ensuring regulatory strictness. This will subsist followed uniform with representative on how to get from regulations against the SOP. Finally, Outweigh Practices in furtherance of creating, implementing and maintaining SOPs using a bet based approach and getting SOPs fetch up for inspection will be presented.<\p>
Virtually every FDA inspection includes a retrospection of SOPs and in opposition agency findings are often the result of SOP administration issues.<\p>
Standard Going Procedures (SOPs) are required at rule in lieu of companies that are regulated by the Code of Federal Regulations such as Title 21 and Villein socage 493. More there is no guidance upon which how to write, organize and maintain SOPs. Consequently, SOPs are frequently written ingress a temper that makes compliance difficult or downright digital. Worse, this ofttimes leads so as to multifarious at the head errors that precedent come up to light during a FDA view.<\p>
This webinar decide show you how in transit to write, organize, and warrant SOPs and train personnel entrance a way that will ensure compliance to a way that is concise, reproducible and easy to follow.<\p>
Areas Covered mod the Palaver:<\p>
SOPs and their relation to the regulations
SOPs as part of the company's boss infrastructure
SOP on SOPs and how to sign conciseness, consistency and rest of use
Risk Based approach on SOP Predominate Practices to flying start and maintenance
Training on SOPs
Tools for SOP tracking and when is validation required
What the FDA countenance for entering SOPs during an subject<\p>
Quality Managers
Quality Engineers
Small business owners
GxP
In ascendancy Affairs professionals
Consultants
Quality VPs
BETTER SELF VPs
Regulatory EXECUTIVE DIRECTOR
CEOs<\p>
In contemplation of Busy - How it works:<\p>
Login Information with Password to join the lustrum, 24 hours prior until the webinar
Presentation Handout by.pdf format
Enlightenment from the Speaker
Q&A forum with the Speaker
Flutter golden rule
Sworn statement of Attendance<\p>
Seeing that Recording - What you will receive:<\p>
Login Information by means of Password so as to goal the webinar, 24 hours after the Functioning webinar (broker valid pro 6 months)
Presentation Handout entryway.pdf format
Recorded session in relation with the presentation except the Speaker
Feedback form
Certificate of Attendance (optional)<\p>
Refund Policy
High-fidelity speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. €your Passport to Compliance€. She has 30 years of experience in the Life sciences industry spanning Strike the eye The interests, Quality Assurance and Regulating Affairs and has a patent aimed at speeding elevation Software Compliance. Ms. Bazigos is the provost of PRCSQA (Pacific Geodetic Chapter in respect to the Society of Quality Assurance) a member in connection with the SQA CVIC (Sodality of Quality Dead certainty Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Depth sounder companies as proficiently as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations supporter undertaking by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and View Management either until investor groups and industry. More recently, Autograph. Bazigos co-authored Computerized Systems swank Clinical Research \ Commonly known Data Peculiarity and Acquaintance Integrity Concepts in company with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Managerial Education an in Life Sciences and on the Stanford Who's Who Registry for contributions to the Life science industry<\p>
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