Price: $2,999.00

Length: 3 Days
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cGMP Training, Current Good Manufacturing Practices Training

cGMP Training, Current Good Manufacturing Practices Training is a 3-day certification program. It covers all aspects of FDA’s regulations on Current Good Manufacturing Practices or cGMP. Learn how cGMP will impact different phases of pharmaceutical, bio-pharmaceutical  and biologic development.

This 3-day cGMP training is an in-depth course covering cGMP key concepts and regulations and mandates including clinical development through post-approval drug and manufacturing.

Key Topics Covered:

  • Steps in cGMP certification
  • cGMP certification preparation and examaition
  • Foundations of the regulations applied to the manufacturers
  • Processes to control the manufacture and distribution of pharmaceutical, biologic and medical devices
  • Key aspects on Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/21
  • Application of the FDA regulations and recommendations
  • Modernization of Food Good Manufacturing Practice Regulations
  • Food CGMP Modernization  and best current Good Manufacturing Practices (cGMPs) practices
  • Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations
  • 21 CFR 600/610 (Biological Products: General)
  • 21 CFR 820 (Quality Systems Regulations)
  • CGMP 21 CFR 210/211 the other Parts (600 and 820)  Part 211
  • Assurance for  proper design, monitoring, and control of manufacturing processes and facilities
  • Assurance of procedures and processes to identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations
  • Guidelines on procedures and processes for establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories
  • Methods to prevent instances of contamination, mix-ups, deviations, failures, and errors
  • Steps to assure that drug products meet their quality standards as specified

Who Should Attend

cGMP training course is designed for anyone who needs a good understanding of  current Good Manufacturing Practices. Learn about CGMP environment, procedures and processes,  roles and responsibilities applied to CGMP quality. Participants will learn about principles of cGMP applied to product analysis and discovery, development, manufacturing, verification and validation. Engineers, PMs, quality assurance professional, quality control managers, regulatory affairs, auditors, production engineers and managers, and management would like to apply current GMP compliance tools and techniques to their environment.

Course Topics

Introduction to cGMP

  • FDA Drug Approval, Regulation and Compliance
  • Drugs and devices
  • Generic drug and devices approvals
  • cGMP Regulations
  • The fundamentals
  • GMP vs. “cGMP”
  • Update procedures
  • Record keeping
  • Personnel qualifications
  • Sanitation
  • Cleanliness
  • Equipment verification
  • Process validation
  • Complaint handling
  • KPIs and controls
  • Tools to analyze, prevent contamination, mixups, and errors

Writing or revising “Standard Operating Procedures” (SOPs)

  • Specifications for pharmaceutical, medical devices, clean room, drug substances and drug products
  • Compiling information
  • Assignment of responsibility for departmental procedures
  • Control of procedures and documentation
  • Instruction on technical writing
  • GMP Audit
  • Checklist for Drug Manufacturers
  • SOP Documentation management and control

cGMP Procedures and Processes Applied

  • Validation for FDA compliance
  • Analytical methods validation for FDA compliance
  • cGMP compliance
  • cGMP audit
  • Strategies for compliance
  • Pharmaceutical quality control
  • Medical devices
  • Clean room technology
  • Design control and product validation and certification
  • Effective complaint system creation
  • Root Cause investigations for CAPA
  • Packaging of pharmaceuticals products
  • Modernization processes
  • Pharmaceutical process development and technology transfer
  • Preparing for FDA inspection
  • Process validation for packaging of pharmaceuticals and medical devices

Workshops and Case Studies

Practical Exercises 

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