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Blue Bell Consulting (BBC) is a leading full-service consulting firm in China while providing world-class professional services for FDA-regulated industries worldwide
Latest Training Course
cGMP Interpretation
and Application
Time:
9/3-9/5/2008
Site:
Shanghai
Instructor:
W. Mel Dong,
PhD
Fee:
RMB 3,800/person
Course Status:
Recruiting
DMF
- Raw Drug Materials and APIs
A Drug Master Files (DMF) provides confidential detailed information about facilities, processes, packaging, and storage of a RDM or API
ANDA
- Generic Drugs
An Abbreviated New Drug Application (ANDA) contains data which provides for the review and ultimate approval of a generic drug product
IND
- Investigational Drugs
An Investigational New Drug Application (IND) is a request for FDA authorization to administer an investigational drug to humans
510(k)
- Medical Devices
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective
IDE
- Investigational Devices
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data
Open Course
Listing
cGMP Interpretation and Application
cGMP for BPCs and APIs
QSR for Medical Devices
cGMP: Compliance Auditing
cGMP for Sterile Drugs
cGMP: Laboratory Controls
cGMP: Batch Records Review
cGMP: Qualification and Validation
Computer System Validation and ER/ES
FDA Regulations: New/Generic Drugs
FDA Regulations: Medical Devices
Clinical Trial: Design and Analysis
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