We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. Read more about our Privacy Policy.

I got it!

Online Webinar
15 Jan 2015
Science

Webinar On FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.

On Going Christmas Offers: Offer valid till 1 st January 20151. Register an attendee for Single Live:Get 10% of on every RegistrationFirst 10 attendees will receive recording Access to the webinar for No Additional CostFor Coupon Code call customer support:  416-915-44582. Register your Group for Corporate Live:Get 15% of on every RegistrationEvery group registrant will receive Recording Access to the webinar for No Additional CostFor Coupon Code call customer support: 416-915-44583. Unlimited viewing for 4 days4. The discounted amount will appear after entering the Coupon Code in the Secure Check Out PageFDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations  and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.Areas Covered in the Session :FDA's current inspection and enforcement practicesFDA's new interpretation: learning from FDA  inspection reportsStrategy for cost-effective implementation of  Part 11: A six step planRecommended changes to existing Part 11 programs to reduce costsJustification and documentation for the FDA and your managementCase studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.How to prepare your company for Part 11 InspectionsWho Will Benefit:A must attend webinar for all personnel / companies in the Pharmaceutical, API, Contract laboratories, Medical device, Clinical testing, CROs and IT consulting fields. The professionals who will benefit include all:IT managers and system administratorsQA managers and personnelAnalysts and lab managersValidation groupsSoftware developersValidation professionalsTraining departmentsDocumentation departmentConsultantsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

15 Jan 2015 @ 01:00 pm

15 Jan 2015 @ 02:15 pm

Duration: 1 hours, 15 minutes

Timezone: GMT -5:00


Where

Online Webinar


Language

English en


Organised by

Compliance Trainings (deactivated)

Other Events in Science

SLS&OPTIROB 2024

Romania, 27 Jun 2024

Similar Webinars in Science

MARIE CURIE ACTIONS Proposal Writing

Netherlands, , 26 Aug 2024

Recent Publications in Science

PASSENGER: a solution for futureproof permanent magnets made in Europe

Fact-sheet, Apr 2024, ESF - PASSENGER project