2 Info-Packed Webinars on Computer Compliance & Cloud Impact

Cloud based software as a Service (SaaS) applications and Cloud services have transformed into major players in the IT marketplace serving life science regulated industries such as Good Practices in Clinical (GCP), Laboratory (GLP), and Manufacturing (GMP) or GXP. Software as a Service (SaaS) uses cloud computing for delivering a single application to multiple users, regardless of their location, rather than the traditional model of one application per desktop. It permits to manage activities from central locations in a one-to-many model, including pricing and management characteristics.
Instructor:
Product ID: PACK70025

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants.
  • Recording links will be valid up to 6 months with unlimited access.
  • Free shipment of CDs within 72 hours from the date of purchase.
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id.

Webinar Topics:


Who will benefit?

  • Industries regulated by GXP (GCP,GLP,GMP), Part 11/Annex 11, HIPAA, and Safe Harbor
  • Pharmaceutical, Biotech, Medical Device industries, Clinical CROs & SaaS/Cloud vendors
  • Quality Assurance, QA Director, Regulatory Compliance Manager, Auditor, IT Director, IT/IS Manager, Software & Data Center vendors to these industries, Validation team, CRO QA, software developer, Project manager, System Owner.

Instructor Profile:

Dr. Teri Stokes worked as a Medical Technologist in hospitals, researches, and central laboratories. Her transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16 year career focused on pharmaceutical computer solutions. Based in Basel, Switzerland 1990-1995, she developed DEC's computer validation consulting practice for customers across Europe and in Japan with a focus on reality-based compliance to global good practice (GCP, GLP, GMP) regulations.


Webinars included in the Package:

Computer Compliance & Cloud Impact Part I - The Auditable Validation (Duration 90 minutes)

This webinar will speak about the compliance of SaaS applications and Cloud technology services used in GXP, Part 11/Annex 11, HIPAA, and Safe Harbor regulated industries.

Industry and IT professionals both new and experienced in computer validation are facing new compliance challenges around the implementation of SaaS and other Cloud technology services for regulated data and GXP operations. It is important for them to examine their compliance practices and see where there is an impact with SaaS and Cloud services that calls for a change in approach or documentation to validation, audit practices and data center contracting procedures.


Objectives of the Presentation:

This webinar will equip attendees to address the following questions in their own professional environment:

  • What is the compliance difference between a SaaS product and a non-SaaS product?
  • How does an industry standard End User performance qualification (PQ) package change with SaaS/Cloud products?
  • What are the audit concerns for assessing SaaS/non-SaaS vendors?
  • What is the impact of SaaS/Cloud on an industry standard Installation Qualification (IQ) validation package?
  • What are the audit concerns for assessing Cloud/non-Cloud data center vendors?
  • What is the SaaS/Cloud impact for developers of Apps used for GXP purposes and their Operational Qualification (OQ) package?
  • Computer Compliance & Cloud Impact Part II - Auditable Formal Testing

Computer Compliance & Cloud Impact Part II - Auditable Formal Testing (90 minutes)

This webinar introduces an industry standard formal software testing model suitable for use by end users, infrastructure providers, and software developers and discusses characteristics of "formal" testing,” key audit/inspection points in a test script template for manual testing and standards for testing data quality in or out of a "Cloud" - ALCOA & CCEA. The presentation will also focus on data quality challenges with cloud practices for duplication of data for ease of storage, global mobility of data across multiple data centers, and documented control of ongoing change control.


Objectives of the Presentation:

This webinar should equip attendees to address the following questions in their own professional environment:

  • What is "formal" testing and how does testing differ across OQ/IQ/PQ work?
  • What does an industry standard formal testing package have in it?
  • What are the key auditable elements in a manual test script?
  • Where is my SaaS App data today and does it matter?
  • How do I protect my GXPdata without having direct physical/logical control of it?
  • How can I leverage SOC I & II audit reports and ISO/IEC 27001:2005 certification reports to support my validation program?
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