Date: | June 9, 2016 - 9:00am - June 10, 2016 - 6:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | Las Vegas, NV, Las Vegas, NV, NV, 89101, United States |
Website for Event: | http://www.mentorhealth.com/control/globalseminars/~product_id=200069SEMINAR |
Topic: | Health Education |
Description: | Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. Why you should attend: This session helps participants: Who Will Benefit: This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include: Agenda: Day One Lecture 1: Speaker: John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. Location: Las Vegas, NV Date: June 9th & 10th, 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON, Las Vegas, NV Price Details: (Seminar Fee for One Delegate Without stay)-Price: $1,295.00 (Seminar Fee for One Delegate With stay)-Price: $1,695.00 Quick Contact: NetZealous DBA as MentorHealth Follows us: Twitter: https://twitter.com/MentorHealth1 |
Contact Name: | Event Manager |
Contact Email: | support@mentorhealth.com |
Contact Phone: | 8003851607 |