Course offering number:0807-728
Course ID:
2230
FDA Quarterly Briefing–July 2008
Pre-recorded Course
90 Minute Accredited Online Training
Who Should Attend
This course is designed for professionals in the pharmaceutical, device and biologics industries. It will be especially beneficial to:-
Regulatory/QA Managers
- Directors and VPs
- Planning Executives anticipating FDA changes
Description
This quarter’s briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and innovations
from the FDA, and places them in context for the pharmaceutical, biological and device professional. This 90–minute accredited
online training is divided into three sections, each section devoted to a new FDA regulation or initiative. Ample time has been
allotted to answer your questions. The topics are:
PUBLIC ADVERTISING GUIDELINES:
Congressional mandate:
2007 Act
Problems and value of public advertising:
Information dissemination
Public demand, over-use
FDA monitoring:
Shift from FTC
Expertise gap
Emerging guidelines:
Clarity
Information without “sales pitch”
Dangers and side effects
GMP AND 21 CFR PART 11 REVISIONS:
Harmonization with EMEA GAMP4/5:
GAMP4= cGMP+Part11
Updating of GMPs in automated environment:
More than ten years since last update
Risk factors
PAT:
Automation of QA function
Potential for remote monitoring
POST MARKET SURVEILLANCE REQUIREMENTS:
Extension of FDA focus:
Reduce NDA/ANDA pressure
Increased most market surveillance
Improved data collection and analysis:
Active rather than passive
Tracking use, side effects
Possible post clinical studies (Phase V?)
Concerns over off label use:
Reconciling distribution volume
Post NDA/ANDA submission and review:
New FDA responsibility
New submission guidelines
Question and Answer Session