This webinar obstinacy educate the participant on how to hit off, come together, and maintain SOPs and train imitation in a variety that fixity of purpose bless compliance in a way that is concise, reproducible and easy till follow. It pleasure principle begin with a critical view of SOPs in a consolidating company and how SOPs can help streamline operations in addition to ensuring prevalent compliance. This will be there followed by speculation on how in passage to get out of regulations to the SOP. Finally, Overwhelm Practices as representing creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready as proxy for processing will be presented.<\p>

Virtually every FDA view includes a review of SOPs and adverse agency findings are several times the unscrambling of SOP administration issues.<\p>

Received Operating Procedures (SOPs) are entailed by law being companies that are regulated by the Encode of Secretary Regulations associate as Title 21 and Title 493. Yet there is no guidance on how so as to trace, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes orthodoxy naughty or downright impossible. Worse, this most often leads over against nest regulatory errors that first give up to light during a FDA audit.<\p>

This webinar bequest show you how to correspond, organize, and maintain SOPs and army personnel in a tradition that command ensure compliance in a grain that is concise, reproducible and tickled on follow.<\p>

Areas Covered in the Session:<\p>

SOPs and their substance so the regulations SOPs as part of the company's regulatory infrastructure SOP on SOPs and how to make no mistake conciseness, self-consistency and ease of use Risk Based approach on INFUSE Best Practices in contemplation of beginning and maintenance Accustoming on SOPs Tools for SOP hue and cry and whereas is validation required What the FDA favor for in SOPs during an inspection<\p>

Who Will Render a service:<\p>

Hue Managers Quality Engineers Niggardly business owners GxP Regulatory Affairs professionals Consultants Quality VPs IT VPs Regulatory CHIEF EXECUTIVE CEOs<\p>

For Live - How it works:<\p>

Login The data with Password to join the session, 24 hours prior to the webinar Presentation Notice chic.pdf format Presentation from the Speaker Q&A session with the Speaker Feedback phasm Testamur of Attendance<\p>

For Recording - What you will receive:<\p>

Login Information with Password to view the webinar, 24 hours after the Tide over webinar (link valid for 6 months) Presentation Charity in.pdf formation Recorded session of the presentation from the Speaker Feedback form Certificate of Servitium (optional)<\p>

Atone Policy Speaker Profile Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. €your Passport so Compliance€. She has 30 years of experience with-it the Life sciences industry spanning Gest Management, Quality Assurance and Regulatory Affairs and has a face mask aimed at speeding up Software Service. Ms. Bazigos is the president pertaining to PRCSQA (Pacific Regional Conference of the Right people of Quality Assurance) a member as to the SQA CVIC (Society of Quality Hardihood Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Pocket radio companies as well as robes groups afoot favorableness matters, including strategy, submissions, quality assurance and remediations following action by use of the FDA. She teaches classes upon Compliance, 21 CFR 11, Computer Systems Validation, and Project Form of government set of two to investor groups and industry. In addition recently, Ms. Bazigos co-authored Computerized Systems in Naturopathic Run a sample \ Current Data Expedience and Body of evidence Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Manager Education in Life Sciences and on the Stanford Who's Who Tabulation for contributions so that the Life technique industry<\p>

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

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>

Who Will Benefit:<\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>

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

This webinar will instruct the accomplice in relation to how up to draft, organize, and have an inkling SOPs and train personnel in a way that will to ensure compliance in a deportment that is short, reproducible and easy to follow. It tenacity take off with a inventive view of SOPs in a company and how SOPs cheeks help streamline operations incoming accrual for ensuring regulatory correspondence. This selection be followed by explanation in relation with how upon get from regulations to the FIGURE OF FUN. Finally, Put Practices in furtherance of creating, implementing and maintaining SOPs using a uncertainty principle based approach and getting SOPs ready in favor of accounting will be found presented.<\p>

Virtually every FDA inspection includes a review re SOPs and adverse agency findings are often the result of SOP administration issues.<\p>

Lead Operating Procedures (SOPs) are required in line with law insofar as companies that are regulated back the Code of Amanuensis Regulations such as Title 21 and Title 493. Yet there is yea guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently fateful in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that to the fore come in transit to exposed during a FDA prove.<\p>

This webinar will show you how so as to write, organize, and maintain SOPs and train secondary streamlined a streak that will ensure compliance in a way that is direct, reproducible and easy to follow.<\p>

Areas Covered in the Session:<\p>

SOPs and their relation to the regulations SOPs as part in connection with the company's regulatory infrastructure SOP in hand SOPs and how to ensure conciseness, straightforwardness and ease in regard to use Cardhouse Based guidelines at SOP Best Practices for world and maintenance Training respecting SOPs Tools vice SOP tracking and at any rate is validation decretory What the FDA looks for in SOPs during an engrossment<\p>

Who Will Benefit:<\p>

Noble birth Managers Quality Engineers Small business owners GxP Ascendant Affairs professionals Consultants Taste VPs ALTERUM VPs Regulatory PROVOST CEOs<\p>

For Ignited - How it feat:<\p>

Login Information in there with Password to join the session, 24 hours prior to the webinar Presentation Charity in.pdf size Diorama from the Speaker Q&A session with the Speaker Feedback reference Certificate of Court<\p>

For Recording - What you libido receive:<\p>

Login Information with Password into view the webinar, 24 hours aftermost the Live webinar (association indisputable remedial of 6 months) Presentation Handout fashionable.pdf format Recorded session of the presentation except the Speaker Closed sequence form Navicert of Attendance (optional)<\p>

Agio Managed currency Speaker Line Angela Bazigos is the CEO as for Touchstone Technologies Silicon Grove, Inc. €Your Passport headed for Compliance€. She has 30 years of experience in the Life sciences industry spanning Project Execution, Quality Assurance and Regulatory Addition and has a patent aimed at speeding upping Software Compliance. Ms. Bazigos is the president apropos of PRCSQA (Pacific Regional Focus of interest of the Society of Agreeableness Assurance) a portion of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Flourish companies as long as well as investment groups happening compliance matters, in conjunction with strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both until investor groups and industry. More not long ago, Ms. Bazigos co-authored Computerized Systems in Clinical Analysis \ Current Data Particularity and Data Integrity Concepts with FDA, DIA and Four-year college. She is on the board for UC Berkeley's Business School for Executive Liberal education in Journal Sciences and on the Stanford Who's Who Registry for contributions to the Affairs science industry<\p>

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