ICH Q7 with Q7 Auditors Check List
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2 Day Drug GMP Boot Camp - November AC
| Don't just get the books! Get the Training! |
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2 Day Pharmaceutical Drug GMP Boot Camp
(21 CFR Part 211 with ICH Q7 API)
'cGMP Training from the Auditor's Perspective'
5 - 6 November, 2018 - Atlantic City, New Jersey
(For Medical Device Boot Camps Click Here) |
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$995.00 USD - Sign-up Today!
Marriott Courtyard
Atlantic City, NJ
All Boot Camps Conferences Includes:
- GMP Seminar Binders
- Handbooks
- Certificates of Attendance
- Breakfast, Lunch and Refreshments
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- Breakfast and Opening Introductions
- GMP 101 The Basics (Satisfies the annual GMP Training Requirements)
- 21 CFR Part 11 Basic Overview
- 21 CFR Part 11 Definitions, System Types and Classifications
- 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
- Part 11.10 Sections a) - k)
- (a) Validation
- (b) Copies of records
- (c) Protection of records
- (d) Limiting system access
- (e) Audit trails
- (f) Operational system checks
- (g) Authority checks (h) Device checks
- (i) Education, Training, Experience
- (j) Policies and Procedures
- (k) Systems documentation
- Risk Analysis - Determine Which Systems Need to be Validated
- Steering Committee and Charters
- Lunch
- 21 CFR Parts 210/211 Drug GMPs - (with ICH Q7 - API Correlations)
- GMPs - The Basics - Quality Definitions, CAPA, Deviations, Non-Conformance
- Organizational & Management Responsibilities
- Document Control Program
- Employee Orientation, Quality Awareness, and Job Training
- Plant Safety and Security
- Internal Quality/GMP Training Session 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
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| Day 2 Topics |
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- Breakfast
- 21 CFR Parts 210/211 Drug GMPs (Cont.)
- 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
- Complaint Handling and Customer Satisfaction Program
- 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
- Lunch
- Recall and Traceability
- cGMP for Sterile Drug
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- cGMP for Phase 1 Clinical
- Questions and Answers
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- Guaranteed Lowest Price
- Quantity Discounts Available
- Always Current, Up-To-Date
- Company Logos Available
- Special Customizations
- Pocket-sized 3.75" x 6.25"
- Prep for FDA & Client Audits
- Employee Training & Reference
- Promotional "giveaways"
- Tradeshows and meetings
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