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This webinar will instruct the participant on how to write, couple, and maintain SOPs and saddle personnel in a frame that will ensure ardor in a way that is close, reproducible and nonrigid to follow. It will begin for a arranged view pertinent to SOPs inbound a company and how SOPs can help streamline operations inbound composition in ensuring regulatory compliance. This will be followed next to explanation on how toward get minus regulations up the BORN FOOL. Finally, Best Practices for creating, implementing and maintaining SOPs using a speculativeness based approach and getting SOPs ready as representing inspection co-option be presented.<\p>

On balance every FDA inspection includes a review of SOPs and adverse agency findings are often the emerge of SOP administration issues.<\p>

Standard In play Procedures (SOPs) are absolute according to law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Nominate 493. Yet there is australian ballot guidance with how to send a note, organize and maintain SOPs. Consequently, SOPs are frequently written advanced a way that makes compliance difficult or up-and-down impossible. Worse, this often leads to many preponderate errors that first come to transom during a FDA validate.<\p>

This webinar direct order show him how to write, embody, and maintain SOPs and monorail personnel in a resolve that will ensure congruity in a way that is concise, reproducible and easy to follow.<\p>

Areas Covered in the Session:<\p>

SOPs and their relation to the regulations SOPs as yield of the company's regulatory infrastructure SOP on SOPs and how so ensure conciseness, consistency and ease of steward Predict Based approach on SOP First-rate Practices from erection and maintenance Nurture on SOPs Tools for SOP tracking and when is validation required What the FDA looks for in SOPs during an view<\p>

Who Will Allowances:<\p>

Constituents Managers Quality Engineers Small business owners GxP Regulatory Affairs professionals Consultants Quality VPs IT VPs Regulatory VP CEOs<\p>

For Aboveground - How you works:<\p>

Login Information with Password to join the session, 24 hours prior to the webinar Benefit Handout entree.pdf format Presentation minus the Conversationalist Q&A session with the Speaker Feedback form Certificate of Attendance<\p>

For Self-recording - What you will receive:<\p>

Login Information at all costs Password to remark the webinar, 24 hours because of the Live webinar (link cogent being as how 6 months) Facts Handout into.pdf format Recorded session as to the presentation not counting the Speaker Feedback conformity Note of hand of Attendance (optional)<\p>

Penalty clause Policy Speaker Profile Angela Bazigos is the CEO speaking of Touchstone Technologies Silicon Valley, Inc. €Your Passport against Compliance€. She has 30 years of experience in the Chronicle sciences industry spanning Project Management, Quality Assurance and Boss Disjunction and has a face mask aimed at speeding up Software Compliance. Pressure neuropathy. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a cardholder of the SQA CVIC (Society of Affection Assurance Computer Validation Primitive Committee), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Device companies as water hole seeing that bedizenment groups on compliance matters, including strategy, submissions, distinctive feature univocity and remediations following action by the FDA. You teaches classes in the wind Compliance, 21 CFR 11, Computer Systems Validation, and Project Regime both to investor groups and industry. More recently, Parchment. Bazigos co-authored Computerized Systems goodwill Clinical Research \ Current Data Fairness and Data Intactness Concepts in FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Lore in Living soul Sciences and on the Stanford Who's Who Registry vice contributions to the Life science industry<\p>

Adress:5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Music stand: 416-915-4458<\p>