21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

Start Date : October 12, 2017
End Date : October 13, 2017
Time : 8:30 am to5:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Description

 

 

Course “21 CFR Part 11 compliance for software validation and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Overview:

 

 

Course Objectives:

 

 

Who will benefit:

 

 

 

Agenda:

 

Day 1 Schedule

 

Lecture 1:

Introduction to the FDA

Lecture 2:

21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures

Lecture 3:

The Five Keys to COTS Computer System Validation

 

Day 2 Schedule

 

Lecture 1:

Ten-Step Process for COTS Risk-Based Computer System Validation

Lecture 2:

How to Write Requirements and Specifications

Lecture 3:

How to Conduct a Hazard Analysis/Risk Assessment-Exercise

Lecture 4:

Software Testing

Lecture 5:

System Change Control

Lecture 6:

Purchasing COTS Software

Lecture 7:

Cost Reduction Without Increasing Regulatory or Business Risk

 

 

Speaker

David Nettleton

FDA Compliance Specialist,

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation – Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

 

 

 Location:  Zurich, SwitzerlandDate:  October 12th & 13th, 2017 and Time: 8:30 AM to 5:00 PM

Venue:    Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 31, Early Bird Price: $1,695.00 From September 01 to October 10, Regular Price: $1,895.00

Register for 5 attendees Price: $5,085.00 $8475.00 You Save: $3,390.00 (40%)*

Register for 10 attendees   Price: $9,322.00   $16,950.00 You Save: $7,628.00 (45%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900924SEMINAR?meetings4docs-October-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

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Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com


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