Ten-Step Process for COTS Risk-Based CSV | Course 2018

Start Date : May 8, 2018
End Date : May 9, 2018
Time : 8:00 am to5:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

Website

Description


Course “How to be Efficient and Compliant with Part 11, 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:

Agenda:

Day 1 Schedule


(8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)


8:00am to 8:30am registration


8:30am class starts


Lecture 1: Introduction to the FDA (1:30) {1:30}


Lecture 2: 21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (4:00) {5:30}


Lecture 3: HIPAA Compliance for Electronic Records (0:30) {6:00}


Lecture 4: The Five Keys to COTS Computer System Validation (0:30) {6:30}


Lecture 5: The Validation Team (0:30) {7:00}

Day 2 Schedule


(9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)


Lecture 6: Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}


Lecture 7: How to Write Requirements and Specifications (0:30) {1:30}


Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}


Lecture 9: Software Testing (1:00) {3:00}


Lecture 10: System Change Control (0:30) {3:30}


Lecture 11: Purchasing COTS Software (0:30) {4:00}


Lecture 12: Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

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 270 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.

 

Location:  Salt Lake City, UT Date: May 8th & 9th, 2018 and Time: 8:00 AM to 5:00 PM

Venue:  Hilton Garden Inn Salt Lake City Airport   4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Until April 10, Early Bird Price: $1,295.00 From April 11 to May 06, Regular Price: $1,495.00

Sponsorship Program benefits for “Ten-Step Process for COTS Risk-Based CSV | Course 2018

” seminar

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 – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901648SEMINAR?SEO

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

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel          

 

 

 

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Registration Info

Registration link :   https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901648SEMINAR?may-2018-seo-meetings4doc

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


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