Singapore Seminar on FDA Data Integrity for Computerized Systems

  • Check with publisher
  • Published date: February 16, 2017
    • Singapore, Singapore, Singapore

Overview:
The Problem:
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following?
• Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News
• Overview and Key Requirements of Part 11 & Annex 11
• How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance?
• How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject is skyrocketing!
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems

Location: Singapore Date: April 24th & 25th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867
Tel: (65) 6235 7788

Price:

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

Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*

Until March 10, Early Bird Price: $1,695.00 from March 11 to April 22, Regular Price: $1,895.00

Quick Contact:
NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?channel=mailer&camp=seminar&AdGroup=science-marketplace_april_2017_SEO
Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel



Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • FDA and ISO Compliance Personnel Training - 2017

    FDA and ISO Compliance Personnel Training - 2017

    Pharmacology - Drug Development Fremont (California) May 15, 2017 Check with publisher

    Overview: To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. Areas Covered in the Session: ...

  • The Complete Payroll Law and Best Payroll Service 2017

    The Complete Payroll Law and Best Payroll Service 2017

    Pharmacology - Drug Development Baltimore, MD ( Baltimore, MD) February 24, 2017 Check with publisher

    Overview: This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, requi...

  • Effective FDA and ISO Management Reviews

    Effective FDA and ISO Management Reviews

    Pharmacology - Drug Development Fremont (California) February 21, 2017 Check with publisher

    Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and e...