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

  • Check with publisher
  • Published date: February 16, 2017
    • Sao Paulo, Sao Paulo, Brazil

Overview:
• This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
• Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
• The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
• Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
• This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
• Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
• Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
• Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
• This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Location: Sao Paulo, Brazil Date: June 22nd, 23rd, 2017 and Time: 8:30 AM to 5:00 PM

Venue: WILL BE ANNOUNCED SOON

Price:

Price: $1,095.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,285.00 $5,475.00 You Save: $2,190.00 (40%)*

Until May 10, Early Bird Price: $1,095.00 From May 11 to June 20, Regular Price: $1,295.00

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=900948SEMINAR?channel=mailer&camp=seminar&AdGroup=science-marketplace_june_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...