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X-WR-CALNAME:From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life-Sciences SaaS and AI Companies
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UID:from-soc-2-to-21-cfr-part-11-the-compliance-roadmap-for-life-sciences-saas-and-a@aiweek.boston
DTSTAMP:20260930T172435Z
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DTSTART;TZID=America/New_York:20261021T110000
DTEND;TZID=America/New_York:20261021T120000
SUMMARY:From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life-Sci
 ences SaaS and AI Companies
DESCRIPTION:Selling AI or SaaS into pharma and biotech? Your SOC 2 report
  gets you into the conversation\, but life-sciences buyers will also ask 
 about quality systems\, validation\, audit trails\, electronic signatures
 \, and whether 21 CFR Part 11 applies to your product.\n\nIn this free\, 
 practitioner-led webinar\, Cycore walks through what pharmaceutical\, bio
 technology\, and clinical research customers expect from their software a
 nd AI vendors\, how much of your existing security program you can reuse\
 , and how to build an actionable plan for the next 90 days.\n\nWhat we'll
  cover:\n- How SOC 2\, ISO 27001\, and 21 CFR Part 11 fit together in a l
 ife-sciences customer review\n- Which work from your existing security pr
 ogram carries over\, and what's new\n- Regulated-use considerations: inte
 nded use\, validation support\, audit trails\, electronic signatures\, an
 d record retention\n- Case study: lessons from an AI vendor's pharmaceuti
 cal customer audit\n- A practical 90-day roadmap for your team\n\nWho sho
 uld attend:\nSoftware\, SaaS\, data\, and AI companies selling—or prepari
 ng to sell—into pharmaceutical\, biotechnology\, clinical research\, labo
 ratory\, and other regulated life-sciences organizations. It's especially
  useful if you:\n- Already have SOC 2 or ISO 27001 and need to understand
  what comes next\n- Are deciding whether to pursue SOC 2\, ISO 27001\, IS
 O 9001\, or another framework\n- Have received quality\, validation\, sec
 urity\, or electronic-record requirements from a life-sciences customer\n
 - Need to determine whether and how 21 CFR Part 11 applies to your produc
 t's intended use\n\nIn the seat: founders\, CEOs\, CTOs\, COOs\, product 
 and engineering leaders\, security leaders\, and quality or compliance le
 ads.\n\nSpeakers:\n- Kevin Barona\, Founder & CEO\, Cycore\n- Jai Sisodia
 \, Principal Advisor\n\nFormat: 45-minute presentation followed by 10–15 
 minutes of live Q&A.\n\nEvery registrant receives the replay and a resour
 ce pack (compliance roadmap\, applicability checklist\, control crosswalk
 \, sample customer requests\, and a 90-day planning worksheet)\, whether 
 or not you attend live.
LOCATION:https://www.cycoresecure.com/webinars/the-compliance-roadmap-for
 -life-sciences-software-companies
URL:https://aiweek.boston/schedule/from-soc-2-to-21-cfr-part-11-the-compl
 iance-roadmap-for-life-sciences-saas-and-a
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DESCRIPTION:From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life
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DESCRIPTION:From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life
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