Course Description:

Are you considering moving your data into the cloud, but are worried about compliance issues and loss of control? Would you like to benefit from outsourcing critical IT infrastructure while maintaining confidentiality, integrity, and availability of your data? You are not alone. The good news is that even heavily regulated industries can move into the cloud so long as it is done and maintained in a properly documented and controlled manner.

This cloud compliance seminar will provide an overview of the steps necessary to transition in - and out - of cloud-based hosting while maintaining control over your data. It will cover the concept of “the cloud”, its risks and benefits, and the necessary controls to ensure confidentiality, integrity, and availability of your data. Control frameworks will be assessed, including ISO 27001: 2013, SSAE 16, FDA-compliant quality systems and 21 CFR Part 11. An emphasis will be placed on controls including contracts/Service Level Agreements, usage policies, proper vendor selection, and auditing and inspections.

This seminar is a combination of presentation and workshop designed to leverage the expertise of the instructor and the attendees. Attendees of the seminar will receive a toolkit to assist in cloud vendor management.

Learning Objectives:

Key goals of this course are:

  • To provide an understanding of the risks and benefits of moving regulated operations into the cloud
  • To effectively mitigate risks through vendor selection, contracts, auditing, monitoring and exit strategies
  • To meet/exceed regulatory expectations and to ensure the organization is prepared for inspections
  • The course will focus on the following key aspects of cloud based compliance:
    • Vendor Selection
    • Quality Systems
    • Security
    • Certifications
    • Contracts
    • Auditing
    • Implementation
    • Decommission
  • To discuss key case studies of litigation and enforcement
  • Attendees will be prepared to select and manage a cloud hosting vendor

Who will Benefit:

  • IT Professionals
  • Systems Owners
  • Quality Auditors
  • Compliance Officers
  • QA Professionals
  • Regulatory Affair Personnel
  • Compliance Consultants
  • Risk Managers
  • Chief Security Officers (CSOs)
  • Chief Technology Officers (CTOs)
  • Security and Control Professionals
  • Senior Management

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Welcome and Introductions (30 Minutes)
  1. Understanding the Basics (1 Hour)
    1. What is the cloud?
      1. Concepts and Technology
      2. Risks and Benefits
  2. Risk Assessment (1 Hours)
    1. C-I-A
      1. Confidentiality
      2. Integrity
      3. Availability
    2. Risks
      1. Business
      2. Regulatory
  3. Selecting a Vendor (2.5 hours)
    1. Identifying the field
      1. Capabilities
      2. Locations
      3. Certifications and claims
    2. Requirements
      1. Gathering without vendor input
      2. Turning requirements into unweighted questions
    3. Request for Proposal
      1. Format and submission
      2. Evaluating responses
      3. Vendor demos
      4. Final selections
  4. Auditing and the Contract (2.5 hours)
    1. Qualifying Audit
      1. Importance and timing
      2. Logistics
      3. Areas of importance
    2. The Contract
      1. What it should contain
      2. When it should be signed
      3. As a basis for routine surveillance audits

Welcome (15 Minutes)

  1. Control Frameworks (3 Hours)
    1. Quality Systems in general
    2. SSAE 16
    3. ISO security standards, including 27001:2013
    4. 21 CFR Part 11
  2. Implementation and Migration (2 hour)
    1. Qualified infrastructure
    2. Software Validation
    3. User Acceptance Testing and Performance Qualification
  3. Monitoring (30 minutes)
    1. Performance
    2. Change Control
    3. Supplemental audits
    4. Remedies
  4. Decommission and Archive (30 minutes)
    1. Exiting for cause - safeguards
    2. Planned exit
    3. Data Archival
    4. Data scrub
  5. Litigation and Enforcement (30 minutes)
    1. Key cases
    2. Takeaways
  6. Conclusion/Wrap up session (30 minutes)

Meet Your Instructor

Sean Develin
Director, DevRose Systems Ltd.

Sean Develin is the co-founder of DevRose Systems, a UK-based consultancy delivering IT governance and infrastructure and regulatory compliance solutions to companies worldwide. Between 2009 and 2010, he helped launch the MUSA Validated Cloud, one of the first GxP compliant private clouds available to the Life Sciences industry. Mr. Develin’s expertise includes validation, auditing, and vendor management. He is an adjunct faculty member of the Temple University School of Pharmacy and is completing his J.D. at Widener University School of Law.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
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  • 10% discount to media partner's subscribers.

Media Partner to do
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  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions

The North Carolina Museum of Natural Sciences (NCSM), located in Raleigh, is the oldest established museum in North Carolina and the largest museum of its kind in the Southeast. It has about 1.2 million visitors annually and is the state's most popular museum or historic destination among visitors. This natural history museum features dinosaur and whale skeletons, live animals, walk-through dioramas, special exhibits, hands-on science education and accessible scientists. The museum's campus consists of four facets: the Nature Exploration Center, the Nature Research Center, the Prairie Ridge Ecostation satellite facility and outdoor classroom, and the North Carolina Museum of Forestry.

The Neuse River Trail is a 33-mile paved greenway located in the Research Triangle region of North Carolina, running along the banks of the Neuse River from Falls Lake Dam to the town of Clayton. The Neuse River Greenway trail is part of the Capital Area Greenway system as well as the Mountains-to-Sea Trail that crosses North Carolina from the Great Smoky Mountains to the Outer Banks. Open to both cyclists and pedestrians, the Neuse River Trail is the longest greenway trail in North Carolina and the longest paved trail between northern Virginia and western Georgia.

The North Carolina Museum of Art (NCMA) opened in 1956 as the first major museum collection in the country to be formed by state legislation and funding. The museum has continued to be a model of enlightened public policy with free admission to the permanent collection. It encompasses a collection that spans more than 5,000 years of artistic work from antiquity to the present, an amphitheater for outdoor performances, and a variety of celebrated exhibitions and public programs. The museum features more than 40 galleries as well as more than a dozen major works of. One of the leading art museums in the American South, the NCMA recently completed a major expansion, winning international acclaim for innovative approaches to energy-efficient design.

Pullen Park is a 66.33-acre public park in Raleigh, adjacent to the campus of North Carolina State University. The park features picnic areas, a concessions stand along with several small rides including the Pullen Park carousel, train, and kiddie boats. Pedal boats are also available for rent seasonally on the park's large pond. The Pullen Aquatic Center, Pullen Arts Center and Theatre in the Park are also located on the park grounds. It is one of the most famous and known parks around the Raleigh/Durham area.

Carolina Ballet is a ballet company founded in 1997 which performs primarily in Raleigh and throughout the state. It has also toured to New York City, Hungary, and China. One of Carolina Ballet's most popular performances, The Nutcracker, is performed annually. Carolina Ballet currently has about 35 dancers.

Marbles Kids Museum is a nonprofit children's museum located in downtown Raleigh in the Moore Square Historic District. Its mission is to "inspire imagination, discovery and learning through extraordinary adventures in play and larger-than-life IMAX experiences." Marbles Kids Museum offers unique hands-on interactive experiences that inspire children to be creative thinkers and active learners. Its permanent exhibits are intended for children under 10 years of age and include Around Town, Splash!, IdeaWorks, Power2Play, and Moneypalooza. Daily activities and numerous special events are organized around Marbles' mission and child-centric core initiatives. The museum offers affordable daily admission and annual memberships and access programs for children from low-income families and children with disabilities.

The JC Raulston Arboretum is a 10-acre (40,000 m2) arboretum and botanical garden administered by North Carolina State University, and located at 4415 Beryl Road, Raleigh, North Carolina. It is open daily to the public without charge. Its plant collections now include over 6,000 species of perennials, bulbs, vines, ground covers, shrubs, and trees, with significant collections of maple, oak, buckeye, barberry, boxwood, redbud, holly, magnolia and more.

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