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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. 


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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.


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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:
  • CGMPs for Pharmaceutical Life Cycle Management - Our NEW GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management course will provide an orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical product. View course dates now.

  • Pharmaceutical Quality Assurance and Control - This course will have discussions that include the role of quality and the major elements of pharmaceutical quality, the impact of management practices, the features of an effective quality organization, quality management throughout the product life cycle – including GMPs compliance, and the role of corporate quality.

  • Pharmaceutical cGMP-Quality Systems - This 90 minute online course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality System, the primary system of FDA's Systems Based Inspection Program. View course summary now.

  • cGMP for Personal Care, Cosmetic and OTC Products - This 2-day intensive course will provide an in depth overview of Current Good Manufacturing Practices for personal care, cosmetic and OTC products and will highlight how the Quality Systems approach can support regulatory compliance not only in the United States, but also the European Union. View course summary now.

  • Introduction To Pharmaceutical cGMP - This 90-minute accredited training course introduces the employee to the cGMP environment. View course summary now.


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
Auditing for GMP Compliance 
Barrier/Isolater Technology for FDA Regulated Facilites 
Batch Records: Simplified and Clarified
Biopharmaceutical Process Systems 
CAPA - The Heart of Your Quality System 
cGMP and Quality Issues for Biopharmaceuticals 
cGMP Auditing - Strategies for Compliance 
cGMP for Pharmaceutical Quality Control Laboratory Personnel 
cGMP Regulations for Pharmaceutical Corporate Executives 
CGMPs for Pharmaceutical Life Cycle Management
Change Control/Deviations 
Clean Room Technology 
Commissioning, Qualification and Validation 
Conducting Effective Quality Audits
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 
Establishing a Risk-Based Compliant Calibration Program 
Excipient GMPs 
FDA Drug Approval, Regulation and Compliance
Generic Drug Approvals
GMP for Dietary Supplements
GMP/QSR/QSIT for Medical Devices 
ICH Q10: Pharmaceutical Quality System 
ICH-Q7/Q11
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 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)
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 
Clinical Studies for Medical Devices 
CMC Writing and Submission Strategies: A Global Regulatory Approach
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  

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