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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Understand what is expected in 21 CFR Part 11 and Annex 11 inspections

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Details

Course "How to be Efficient and Compliant with Part 11, 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.

  • 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.

 

Speaker:

Carolyn Troiano

Consultant, BrainStorm Central Consulting

 

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

Location:  Boston, MA Date: February 4th & 5th, 2019 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:

1 ATTENDEE

$1,295.

You Save: 00

(00%)*

Regular Price: $1200.

Register for 1 attendee

5 ATTENDEES

$3,885.

You Save: $2,590.

(40%)*

Regular Price: $6,475.

Register for 5 attendees

10 ATTENDEES

$7,122.

You Save: $5,828.

(45%)*

Regular Price: $12,950.

Register for 10 attendees

 

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/seminar/how-to-be-efficient-and-compliant-with-part-11-validation-and-SaaS-Cloud-901921SEMINAR?seo

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

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Prices

Price: 1 ATTENDEE $1,295. You Save: 00 (00%)* Regular Price: $1200. Register for 1 attendee 5 ATTENDEES $3,885. You Save: $2,590. (40%)* Regular Price: $6,475. Register for 5 attendees 10 ATTENDEES $7,122. You Save: $5,828. (45%)* Regular Price: $12,950. Register for 10 attendees Sponsorship Program benefits for seminar For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact

Net Zealous LLC - DBA GlobalCompliancePanel
globalcompliancepanel@gmail.com

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