SME Interactive TEAMs Segments:

4, 8 and 16 Hour GXP Live Interactive Training Sessions.
Hosted by Industry Professional FDA and EMA SMEs

     

GMP - The Basics 101

  • GMP QMS 101 The Basics
  • The GMP Lifestyle
  • Agency Inspections and 483s
  • Good Documentation Practice 101
  • GMP 11 General Orders
    1. Write Procedures
    2. Follow Procedures
    3. Documentation
    4. Validation
    5. Build Facilities
    6. Maintaining Facilities
    7. Competency
    8. Good Housekeeping Practices
    9. Control for Quality
    10. Audit for Compliance
    11. Prepare for Battle - Recall and Traceability Audits
 

Course GMPB101

The very basic GMP requirements to satisfy your GMP Training needs.

Designed for every person seeking to work in the regulated industry under Title 21 Food and Drug Administration requirements.

 

 

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GMP - Quality Management Systems Components

Purpose, Rationale and Components of the Quality Management System (QMS)

  • CAPA - The basics about Corrective and Preventive Actions
  • Non-Conformance - Materials Supply, to End of Use Complaints
  • Change Control - Documentation, Engineering, Production and Distribution
  • Deviations - Deviation management essentials
  • Out of Specifications / Out of Trend - Management of OOS and OOT
  • Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution
  • Recalls - The process, and indications of failures and Product Traceability
  • Audit - Internal, Agency, Customers and External Audit
    Vendors, Suppliers and Contractors - Quality Agreements
  • The Meetings - Management and Quality Meetings
 

Course GMPB102

For companies who are seeking to implement the basic QMS components, or preparing for QMS training and understanding of the rationale and failures of QMS programs and components.

 

 

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GMP - Engineering - 21 CFR Part 211 Subpart C Facilities

Subpart C - Buildings and Facilities

  • Site Master Plan
  • Facility Qualification Plan
  • Basis of Design (BOD)
  • §211.42 Design and construction features
  • §211.44 Lighting
  • §211.46 Ventilation, air filtration, air heating and cooling
  • §211.48 Plumbing
  • §211.50 Sewage and refuse
  • §211.52 Washing and toilet facilities
  • §211.56 Sanitation
  • §211.58 Maintenance
  • §211.63 Equipment design, size, and location
  • §211.65 Equipment construction
  • §211.67 Equipment cleaning and maintenance
  • §211.68 Automatic, mechanical, and electronic
  • equipment
  • §211.72 Filters
 

Course GMPB103

Designed for the Engineering, Maintenance and Metrology personnel. Discusses the basics of Facilities design/build and maintenance requirements.

 

 

 

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GMP - 21 CFR Part 11 Compliance

21 CFR Part 11 Electronic Records, Electronic Signatures

  • Scope and Purpose
  • §11.10 Controls for Closed Systems
  • §11.10(a) Validation
  • §11.10(b) Copies of Records
  • §11.10(c) Protection of Records
  • §11.10(d) Limiting System Access
  • §11.10(e) Audit Trails
  • §11.10(f) System Checks
  • §11.10(g) Authority Checks
  • §11.10(h) Device Checks
  • §11.10(i) Proficiency Requirements
  • §11.10(j) Procedures
  • §11.10(k) Documentation
  • Signatures and Record Linking
  • Signatures
  • Passwords
  • Scope and Application 2003
 

Course GMPB104

The FDA's 21 CFR Part 11 requires companies to validate their electronic systems and documents for quality and compliance. Getting and staying into compliance requires understanding the purpose and rationale behind the requirements.

 

 

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GMP - ICH Q7 GMPs for Active Pharmaceutical Ingredients (Overview)

  • Introduction
  • Quality Management
  • Personnel
  • Buildings and Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification
  • Labeling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Rejection and Re-Use of Materials
  • Complaints and Recalls
  • Contract Manufacturers (Including Laboratories)
 

Course GMPB105

The 4-hour segment is the basic description of the sections of the ICH Q7 Guidance.

The 8-hour segment breaks down the sections in more detail.

The 16-hour combines both the ICH Q7 along with 21 CFR Part 211 Drug GMP correlations.

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21 CFR Part 820 Medical Device QSR GMPs

  • GMP 101 - The Basics
  • 21 CFR Part 11 Overview
  • Quality System Requirements
  • Management responsibility
  • Quality audit
  • Personnel
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and process controls
  • Inspection, measuring, and test equipment
  • Process validation
  • Acceptance Activities
  • Receiving, in-process, and finished device acceptance
  • Acceptance status
  • Nonconforming product
  • Corrective and preventive action
  • Device labeling
  • Device packaging
  • Handling
  • Storage
  • Distribution
  • Installation
  • Records - General requirements
  • Records - Device master record
  • Records - Device history record
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques
 

Course GMPB106

The 4-hour segment is the basic description of the sections of the 21 CFR Part 820 QSR.

The 8-hour segment breaks down the sections in more detail.

The 16-hour combines both 21 CFR Part 820 QSR along with ISO 13485 QMS for Medical Device Correlations.

 

 

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GMP WorkBook for up to 10 persons

GMP Handbooks for up to 10 persons

10 Certificates of Attendance for up to 10 persons

Additional sets are available at https://www.auditing.com/payments

 

 

GMP Workbook