Meeting Annual U.S. FDA cGMP Training Requirements
Event contact title
Event Manager
Event contact first name
Adam
Event contact last name
Fleaming
Email
support@compliance4All.com
Event contact telephone number
18004479407
Fax
302-288-6884
Notes
Overview:
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversight of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. There will be no return to the past. Rather than be caught unprepared, proactively address these trends, and start to address areas of known deficiencies through a proactive training program. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. We will also discuss proven methods to address such training needs.
Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal cGMP compliance training to get 'in sync' with the FDA's shift in focus. Refine your training to address areas of known deficiencies and areas of special FDA concern. Use such to increase productivity. Start immediately.
Areas Covered in the Session:
Focus on key cGMP issues
Avoid complacency from past "good" FDA / ISO compliance
Developing the Annual Lesson Plan(s)
The major 21 CFR issues in 111, 210 / 211, and 820
Defect recognition
How to address known problem areas during cGMP training
Stop unauthorized changes -- Prove 'in control'
Monitor and maintain 'the edge'
Description
We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. We will also discuss proven methods to address such training needs.
Attendee information
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants; others tasked with project leadership responsibilities
Future dates
Wednesday, August 26, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Minutes
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link: http://www.compliance4all.com/control/w_product/~product_id=500443LIVE/
support@compliance4all.com
www.compliance4all.com
