CFPA Home Page
QuickJump
 
               
Browse By Industry
Good Manufacturing Practices (GMP) Training Courses from CfPA


Good Manufacturing Practices (GMP) Training

WHY IS GOOD MANUFACTURING PRACTICES (GMP) TRAINING IMPORTANT?
Regulatory agencies are legally entitled to conduct unannounced inspections if they believe there are suitable grounds for doing so.  These regulatory agencies include many European national organizations and the U.S. FDA. GMP Training, therefore, is important so your organization can comply with industry and government good manufacturing practices, specifications, and regulations. 

As the leader in continuing education and accredited technical training, The Center for Professional Advancement (CfPA) offers the most state-of-the-art, cutting-edge GMP training available. Our comprehensive curriculum of online and public GMP training courses run one- to five- days in length and include discussions, case studies, and group exercises which are taught by top industry leaders who share their knowledge in an enthusiastic, interactive manner. 


Browse GMP Training
Courses
-click here or scroll down.
  

Good Manufacturing Practices (GMP) Highlights

WHAT ARE GOOD MANUFACTURING PRACTICES (GMP)?
Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of:

  • Drug substances and drug products

  • Medical devices

  • In vivo and in vitro diagnostic products

  • Foods

The term "cGMP" is used by the federal government as current good manufacturing practices. By definition, "cGMP" indicates that the current GMP - which is "state of the art" - can change. "GMP" and "cGMP" are often used interchangeably and essentially they have the same meaning.


WHO ENFORCES GOOD MANUFACTURING PRACTICES (GMP)?
    • Good Manufacturing Practices are enforced in the United States by the FDA (Food and Drug Administration)
    • Good Manufacturing Practices are enforced in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA)
    • Good Manufacturing Practices are enforced in Australia by the Therapeutical Goods Administration (TGA)
    • Good Manufacturing Practices are enforced in India by the Ministry of Health, multinational and/or foreign enterprises and those individuals in the following positions:

    Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly.

Browse GMP/cGMP Training
Courses
-click here or scroll down.

  
WHAT ARE SOME GMP/cGMP TRAINING COURSES OFFERED BY CfPA?
The following GMP/cGMP training courses offered by CfPA focus on good manufacturing practices, regulations, and guidelines:


WHEN & WHERE CAN I GET GOOD MANUFACTURING PRACTICES (GMP) TRAINING?

Browse other Good Manufacturing Training Courses listed below. CfPA can also bring any GMP Training Course to your location. Please click here for more information about our Client-Site Programs.

Course TitleScheduled
Active Pharmaceutical Ingredients
Adverse Drug Event Monitoring and Reporting 
Analytical Methods Validation for FDA Compliance
Annual Product Reviews for the Pharmaceutical and Related Industries
Applied cGMPs for Pharmaceutical and Allied Industries 
Auditing for GMP Compliance 
Barrier/Isolater Technology for FDA Regulated Facilites 
Biopharmaceutical Process Systems 
Calibration in the FDA Regulated Industry 
CAPA - The Heart of Your Quality System
cGMP and Quality Issues for Biopharmaceuticals 
cGMP Auditing - Strategies for Compliance 
cGMP for Pharmaceutical Production Supervisors 
cGMP for Pharmaceutical Quality Control Laboratory Personnel 
cGMP Regulations for Pharmaceutical Corporate Executives 
Change Control/Deviation 
Choosing Sensors, Monitors and Instruments for PAT Programs
Clean Room Technology 
Commissioning, Qualification and Validation 
Conducting Effective Quality Audits
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT
Critical Process Cleaning and Cleaning Validation 
Current Good Manufacturing Practice (cGMP) for Purchasing 
Current Good Tissue Practices (cGTPs) 
Design Control and Product Validation 
Developing and Maintaining an Effective Complaint System
Developing Specifications for Drug Substances and Drug Products
Documentation Management and Control
Drug Product Stability and Shelf-Life
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 
Environmental Control and Monitoring 
Excipient GMPs 
FDA Drug Development and Compliance
Generic Drug Approvals 
GMP for Dietary Supplements
GMP/QSR/QSIT for Medical Devices 
ICH Q10: Pharmaceutical Quality System 
ICH-Q7
IQ, OQ, PQ
Labeling OTC Drugs 
Laboratory Control System 
Medical Device Quality Systems: How to Comply with Global Regulations
Medical Device Regulatory Compliance 
Microbiological Control and Validation
Outsourcing Pharmaceutical Operations 
Packaging of Pharmaceuticals
Pharmaceutical Aerosol Technology 
Pharmaceutical Coating Technology 
Pharmaceutical Laboratory Information Management System (LIMS) 
Pharmaceutical Process Development 
Pharmaceutical Production and QA/QC Records and Reports 
Pharmaceutical Quality Assurance and Control 
Pharmaceutical Supervisory Management Skills 
Pharmaceutical Technology Transfer
Pharmaceutical Water Systems 
Preparing for and Surviving an FDA Inspection
Principles of Process Validation 
Process Validation for Packaging of Pharmaceuticals and Medical Devices
Process Validation for the Pharmaceutical and Medical Device Industries 
Qualification and Validation of Analytical Methods for Protein Products 
Quality System 
Real World Approaches to PAT and QbD Implementation 
Registration of Pharmaceutical Products in the European Union 
Regulatory Compliance for the Personal Care Products Industry
Risk Management Today: Complying with the ISO 14971: 2007 Standard 
Root Cause Investigation for CAPA
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes) 
Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
Statistical Process Control for PAT 
Sterile Products: Formulation, Manufacture and Quality Assurance
Sterilization in the Pharmaceutical Industry 
Sterilization Technologies and Process Validation 
Sunscreen Regulation Technology and Product Development
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites 
System Validation, GAMP Harmonization and P.A.T 
Validation and Certification of the Pharmaceutical Quality Control Laboratory 
Validation of Manufacturing and Distribution Computer Systems 
Vendor and Contract Supplier Qualification 
Writing SOPs for cGMP Compliance 

 

Other 'Good Practice' systems, aimed at providing reliable and quality work exist: Good Clinical Practices (GCP) for hospitals and clinicians conducting clinical studies on new drugs in humans; Good Laboratory Practices (GLP) for laboratories conducting non-clinical studies; and Good Distribution Practices (GDP) for wholesalers and distributors.

Collectively these 'Good Practice' requirements are referred to as GxP requirements, and all follow similar philosophies.

Browse the GxP Training Courses listed below. CfPA can also bring any GxP Training Course to your location. Please click here for more information about our Client-Site Programs.  


Course TitleScheduled
Adverse Drug Event Monitoring and Reporting 
Analytical Methods Validation for FDA Compliance
Auditing and Inspecting Clinical Research in the Global Environment 
Auditing and Inspecting Preclinical Research for GLP Compliance 
Biostatistics for the Non-Statistician - Beyond the Basics 
cGTP in a Nutshell
Clinical Studies for Medical Devices 
CMC Submissions in CTD Format
Combination Product Development: Safety/Registration/Approval 
Conducting Effective Quality Audits
Design Control and Product Validation 
Developability Assessment 
Developing Specifications for Drug Substances and Drug Products
Developmental and Reproductive Toxicology 
Documentation Management and Control
Early Stage Clinical Studies for Drugs and Devices 
Generic Drug Approvals 
GLP Study Director 
Good Clinical Practices (GCP) 
Good Distribution Practices 
Good Laboratory Practices (GLP)
INDs/NDAs/CTDs 
Introduction to Drug Delivery Technology 
Monitoring of Clinical Drug Studies 
Non-Clinical Drug Safety Evaluation and Drug Development
Outsourcing Clinical Development 
Pharmacokinetics—ADME Fundamentals 
Practical Biostatistics for the Non-Statistician - The Basics 
Preparation, Packaging and Labeling of Clinical Trial Materials
Preparing for and Surviving an FDA Inspection
Qualification and Validation of Analytical Methods for Protein Products 
Registration of Pharmaceutical Products in the European Union 
Risk Management Today: Complying with the ISO 14971: 2007 Standard 
Selecting and Managing CROs 
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites 
Writing and Implementing Clinical Protocols  

Page copy protected against web site content infringement by Copyscape