ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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8-Hour GMP QMS Webinar Training
Calendar:
- January 25, 2021
- February 23, 2021
- March 23, 2021
- April 27, 2021
- May 25, 2021
- June 22, 2021
- July 27, 2021
GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.
- GMP - What is cGMP and the GMP Lifestyle?
- The Agency History and Objectives
- Roles and Responsibilities
- The 10 Principals of GMP
- Good Documentation Practices (GDocP)
- Facility Management
- The History of GMP, the Agency Inspections and 483s
- Warning Letter Reviews
21 CFR Part 11 Electronic Records
- 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) - - Validation - - Copies of records - - Protection of records - - Limiting system access - - Audit trails - - Operational system checks - - Authority checks (h) Device checks - - Education, Training, Experience - - Policies and Procedures - - Systems documentation • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated • Steering Committee and Part 11 Initiatives
Good Auditing Practice
- The Auditor's Basics 101 'From the Auditor's Perspective'
- The 5 Basic Binders
- The Quality Manual
- IT Strategy Plan
- Standard Operating Procedures
- Validation Documentation
- Drug/Device Documentation
The QMS Basics
- - CAPA - - Non-Conformance - - Change Control - - Deviations - - Out of Specifications / Out of Trend - - Complaints - - Recalls - - Product Traceability - - Audit - Internal, Agency, Customers and External Audit - - Vendors, Suppliers, Contractors and Consultants - - Basic Risk Management - - Training Program
Questions and Answers
Includes: - - Binders (shipped free for US Customers) - - Handbooks - - Certificate of Attendance (Completion)
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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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