FDA Data Integrity: Do’s, Don’ts and Real-World Case Studies

Website https://worldcomplianceseminars.com/webinardetails/436 | Edit Freely

Category

Deadline: June 19, 2018 | Date: June 19, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-01 21:26:11 (GMT+9)

Call For Papers - CFP

Time: 01:30 PM EDT | 10:30 AM PDT | 12:30 PM CDT Duration 90 Minute

Description

Data Integrity audits project a moving goal post. Issues that were top warning letter vote getters have made way for newer ones to include Cybersecurity etc. Our Data Integrity courses which are offered around the world are renowned for addressing such evolving trends. Consequently, they have attracted record attendances. Attendee feedback suggests the uniqueness of our offerings. Particularly significant is the feedback from those who attended similar courses offered by other companies.

Areas Covered

• The definition of data integrity according to regulatory bodies

• The FDA's position on Data Integrity

• Data Integrity Issues & Warning Letters

• Data Life Cycle design and controls

• Roles and responsibilities of different groups in ensuring data integrity

• What data integrity SOPs do auditors expect to see during audits

• Data Integrity in Cloud, Virtualization and Big Data

Who will Benefit

• Pharmaceutical industry / Medical device industry / Healthcare industry personnel

• Developers of software for use in Life Sciences industry

• Validation service providers, IT service providers

• Manufacturing personnel, Manufacturing Automation system vendors and system integrators

• Laboratory personnel

Speaker Profile

Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.

Price: $179 One Dial-in One Attendee | Corporate Live Recorded $249 One Dial In - Max 10 attendees |Group $395 Multiple locations upto 5 dial in | Recorded $195