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.

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 Description

The cGMP Training, Current Good Manufacturing Practices Training covers all aspects of FDA’s regulations on Current Good Manufacturing Practices or cGMP.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Learn how cGMP will impact different phases of pharmaceutical, bio-pharmaceutical and biologic development.

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

Code of Federal Regulations (CFR).  FDA’s portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

The regulations enable a common understanding of the regulatory process by describing the requirements to be followed by drug manufacturers, applicants, and FDA.

  • 21 CFR Part 314 and Part 600. Application and licensing submission requirements for new and generic drug applicants.
  • 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
  • 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.

The following pages provide more information with respect to regulations for particular product types and manufacturing considerations:

  • Compressed Medical Gases
  • Positron Emission Tomography (PET)
  • Field Alert Reports (for NDAs) and Biological Product Deviation Reports (for BLAs)

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.

Training Modules

Module 1: 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, mix-ups, and errors

Module 2: 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

Module 3: 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

Case Studies 1, 2 and 3

  • Steps in cGMP certification
  • cGMP certification preparation and examination
  • 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

Practical Exercises 1, 2 and 3

  • FDA Regulations
  • Roles and Responsibilities
  • Application and licensing submission requirements for new and generic drug applicants.
  • Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
  • Current Good Manufacturing Practice for Finished Pharmaceuticals.
  • Facilities
  • Equipment
  • Process
  • Vendors
  • Control Gates
  • Packaging and Labeling
  • Qualification
  • Validation
  • Laboratory Controls
  • Configuration Control
  • Product Release and Distribution
  • Records
  • Reports
  • Audit
  • Incidents
  • Investigations
  • Quizzes 1, 2 and 3
  • Exam
  • Prepare for the cGMP Certification

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