| The
Biologics Consulting Group, LLC develops training programs based
on our experience with the regulatory process and with frequently
asked questions regarding regulatory issues. Alternatively,
BCG designs training programs for specific clients
upon request. All courses can be presented privately at locations
and on dates convenient to the individual client. This
is a cost effective way to have 10 or more employees trained
in current CBER and CDER policies and expectations. These courses
are also offered periodically throughout the year at various
BCG facilities. |
|
Courses
offered on site at your facility
|
| The
Biologics Approval Process |
Topic
Overview :
| Biologics
and their Regulation |
Clinical
Development |
| Product
Development |
The
BLA Process |
| The
IND Process |
Post
Approval |
| Chemistry,
Manufacturing, and Control |
Guidances/
Guidelines |
More
Information
|
Clinical
Study Documents: Regulatory Requirements
and Review |
Objective:
To understand the regulatory requirements for clinical documentation.
To gain practical experience in the review of clinical documents.
More
Information |
| Process
Validation in Biotechnology: Systems Approach |
|
Objective:
To gain an understanding of common approaches to process
validation in biotechnology, against the background of FDA's
Quality Systems inspections program.
More
Information
Page
Updated:
September 28, 2006
|
