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Course
summary:
An aggressive approach to
introduce the GMP basics for new and existing employees working
under Title 21 Code of Federal Regulations requirements.
This 2 day non-stop
discussion explores every chapter under Parts 210/211 from an
Auditor's perspective with considerations to the company
requirements.
The average course size is
usually no more than 20 persons per session, however additional
sessions are available concurrently.
Day 1:
Topics:
What is GMP?
Title 21 CFRs and the cGMPs under
Parts 210/211
FDA History and Inspection Process
Attitudes and Behavior Patterns
Organizational & Management
Responsibilities
Document Control Program
Employee Orientation, Quality
Awareness, and Job Training
Plant Safety and Security
Internal Quality/GMP Audit Program
Quality Cost Program
Design Control
Facility Design and Layout
Environmental Control Program
Facility Maintenance and Good
Housekeeping Program
Outside Contractor Control Program
Equipment Design and Placement
Equipment Identification
Equipment Maintenance & Cleaning
Measurement Equipment Calibration
Program
Equipment Qualification Program
Material/Component Specification and
Purchasing Control
Material/Component Receipt,
Inspection, Sampling, and Laboratory Testing
Material Component Storage and
Handling
Inventory Control Program
Vendor (Supplier) Control Program
Material/Component/Label
Verification, Storage, and Handling
Equipment/Line/Area Cleaning,
Preparation, and Clearance
Operational Process Validation and
Production Change Order Control
In-Process Inspection, Sampling, and
Laboratory Control
Reprocessing/Disposition of
Materials
Finished Product Verification,
Storage, and Handling
Finished Product Inspection,
Sampling, Testing, and Release for Distribution
Distribution Controls
Marketing Controls
Complaint Handling and Customer
Satisfaction Program
Conclude 1st day topics
21 CFR Part 11 Electronic Records;
Electronic Signatures – Predicate Rule
21 CFR Part 820 Quality Systems
Regulations – Predicate Rule
The Guidance Documents - Quality Systems
Approach to the GMPs
The Auditing Check List for the GMPs
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Training includes course specific training
binders which includes;
The Cost of the two day training is $6,995.00 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. |
Course Curriculums:
GMP Basics - 101
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Cost of the one day training is $6,995.00 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.
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