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21 CFR Part 11 compliance for software validation and SaaS/Cloud - seminar at Brazil

Event Details

21 CFR Part 11 compliance for software validation and SaaS/Cloud - seminar at  Brazil

Time: June 22, 2017 at 8:30am to June 23, 2017 at 5pm
Location: Sao Paulo, Brazil
Street: WILL BE ANNOUNCED SOON
City/Town: Sao Paulo
Website or Map: http://www.globalcompliancepa…
Phone: 1-800-447-9407
Event Type: seminar
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Feb 21

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Event Description

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=safetycommunity_june_2017_SEO

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

  

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