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:

GMPs In-Depth Analysis 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. View course summary now.
Introduction to cGMP System-Based Audits - This introductory online presentation will benefit professionals in the pharmaceutical, medical device and related industries who are responsible for GMP compliance issues. 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.

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 Title	Scheduled
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
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 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
Generic Drug Approvals
GMP for Dietary Supplements
GMP/QSR/QSIT for Medical Devices
GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
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 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
U.S. FDA Drug Development and Compliance
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 Title	Scheduled
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 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