"After we attended David’s (Computer System Validation) training, we implemented the procedures he recommended, and we just had our first FDA inspection with no 483s."
– Pharmaceutical company, San Francisco, CA
Palo Alto, CA (PRWEB) September 15, 2011
ComplianceOnline, a leading provider of FDA regulatory/ compliance trainings will conduct a RAPS certified 2-day seminar from October 20-21, 2011 in Philadelphia, PA, on Computer System Validation: Reduce Costs and Avoid 483s.
The seminar will train companies in FDA regulated industries on proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Attendees can learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
For more information or to register for the seminar, please click here.
This interactive 2-day in-person workshop will address the latest computer system industry standards for data security, data transfer, and audit trails. Attendees will learn how 21 CFR Part 11, the FDA regulatory compliance pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process.
Finally, the instructor, David Nettleton, will review recent FDA inspection trends and discuss on how to streamline SOP authoring, revision, review, and approval.
The seminar will benefit 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.
Conference details (price and location):
The Ritz-Carlton, Philadelphia Hotel
Ten Avenue of the Arts
Philadelphia, Pennsylvania 19102
Date: October 20-21, 2011, 8:30 AM to 4:30 PM Eastern, on both days.
Registration Cost: Only $1199 per attendee (includes all course materials and lunch for the 2 days).
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare(at)complianceonline(dot)com
For more information, please visit the ComplianceOnline website.
About the Speaker:
David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps which provides fill-in-the-blank templates for completing a COTS software validation project.
ComplianceOnline is a Palo Alto-based leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. We have successfully trained over 15000 professionals from 3000 companies to comply with the requirements of regulatory agencies.
Our training programs are designed and delivered by top-rated experts from respective industries. Our trainings are proven, powerful and highly rated by industry practitioners.
Our trainings cater to FDA regulated industries - Biotechnology, Pharmaceuticals, Clinical, Medical Devices, Food, Hospitals & Healthcare - Energy, BFSI, Trade and Logistics, HR and Quality compliance and more.
Please visit http://www.complianceonline.com or call +1-650-620-3937 for more information or to register for our training.