How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud

Start Date : September 11, 2018
End Date : September 12, 2018
Time : 8:00 am to5:00 pm

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

Location :
Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States

Website

Description



Course "How to be efficient and compliant with 21 CFR Part 11, data integrity, 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.


Description:





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:  Boston, MA Date: September 11th & 12th, 2018 and Time: 8:00 AM to 5:00 PM


Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States


Price:


Register now and save $200. (Early Bird)


Until August 10, Early Bird Price: $1,295.00


From August 11 to September 09, Regular Price: $1,495.00


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%)*


Sponsorship Program benefits for seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@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=901654SEMINAR?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

 
Cost :     $1,295.00

Event link :
  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901654SEMINAR?meetings4docs-sep-seo

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: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Health & Nutrition.




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