Conference Description:

Course "21 CFR Part 11 compliance for software 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:
• 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: Singapore Date: June 19th & 20th, 2018 and Time: 8:30 AM to 5:00 PM
Venue: Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867

Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*
Register now and save $200. (Early Bird)
Until May 10, Early Bird Price: $1,295.00 From May 11 to June 17, Regular Price: $1,495.00
Sponsorship Program benefits for “Biostatistics for Non-Statistician” seminar
For More Information- https://www.globalcompliancepanel.com/co ntrol/sponsorship
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NetZealous LLC DBA GlobalCompliancePanel
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