| |
21 CFR Part 11
Electronic Records; Electronic Signatures including;
-
Applicability &
Implementation
-
Preambles
-
Scope and
Applications (Aug. 2003)
-
Computerized
Systems Used In Clinical Investigations (May 2007)
-
General
Principle of Computer Systems Validation
In-depth approach to compliance requirements pertaining to
electronic systems, software and hardware.
The Cost of the one day training is $4,995.00 US*
Includes:
- Travel within the Continental United States*
- 20 Material Binders
- 20 Mini-Regulation Handbooks
- 20 Certificates of Completion
- Hotel
- Car Rental
- Expenses
*Allow 45 days notice. Additional charges may apply if within 45
days notice. Additional travel and hotel expenses will apply for
travel outside the Continental United States - Call (866) -
497-6397 for details.
To Secure you date - Press >
|
Course Curriculums:
Electronic
Compliance 101 - Part 11
|
|
Cost of the one day training is $4,995.00 US*
Includes:
- Travel within the Continental United States*
- 20 Material Binders
- 20 Mini-Regulation Handbooks
- 20 Certificates of Completion
- Hotel
- Car Rental
- Expenses
*Allow 45 days notice. Additional charges may apply if within 45
days notice. Additional travel and hotel expenses will apply for
travel outside the Continental United States - Call (866) -
497-6397 for details.
To Secure you date - Press >
|
Basic GMP
101 - w/ Predicates
|
-
Applicability & Implementation
-
Good Manufacturing Practice
-
21 CFR Part 210/211
Predicate Rules – Parts 11 & 820
-
GMPs for the 21st. Century – A risk based approach
Price & Details... |
Quality
Systems Regulations 101
|
-
21 CFR Part 820 QSR
-
Applicability & Implementation
-
Predicate Rules – Parts 11 & 210/211
-
GMPs for the 21st. Century – A risk based approach
-
Quality Systems Approach to the GMPs
Price & Details... |
Good
Auditing Practices 101
|
-
Auditing against the GMPs
-
Auditing against the Predicate Rules
-
Concepts and Development
-
Risk
Assessment
Price & Details... |
|
