Combination Drug/Device Products CGMPs - Final Rule

Website http://bit.ly/1HUI9gZ | Edit Freely

Category FDA Compliance;

Deadline: April 08, 2015 | Date: April 08, 2015

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

Updated: 2015-03-31 20:18:46 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they've considered the applicable elements of the pharma and device CGMPs, 21 CFR 210/211 and 820; sometimes with ambiguous advice from the agency, resulting in some disagreements during compliance audits.

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, medical device, and biologics fields. The employees who will benefit include:

Senior management

Regulatory affairs

Quality assurance

Production

Engineering

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.

Note:

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

For Registration:

http://www.complianceonline.com/the-new-combination-drug-device-products-cgmps-final-rule-webinar-training-702810-prdw?channel=ourglocal