THIS CAPA PROGRAM PROVIDES THE FRAMEWORK FOR AVOID 2015 - How to Avoid an FDA Warning Letter with a Strong CAPA Program

Website http://bit.ly/17CrMuk | Edit Freely

Category FDA Audits and Inspections;

Deadline: March 04, 2015 | Date: March 04, 2015

Venue/Country: Palo Alto, U.S.A

Updated: 2015-02-27 13:30:00 (GMT+9)

Call For Papers - CFP

Description

This course is appropriate for professionals who work within and manage a quality discipline for their organization.

A strong and manageable CAPA program is critical in an FDA regulated environment. Over 50 warning letters have been issued to manufacturers in the medical device industry because of inadequate quality system procedures.

Who Will Benefit:

This course is appropriate for professionals who work within and manage a quality discipline for their organization.

Engineers

Investigators

QA/QC Professionals

Manufacturing Supervisors

Technicians

Instructor Profile:

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D).

Use coupon code 232082 and get 10% off on registration.