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Good Clinical Practice (GCP) Training Courses from CfPA


Good Clinical Practice (GCP) Training

WHY IS GOOD CLINICAL PRACTICE (GCP) TRAINING IMPORTANT?
Any organization conducting a clinical trial on a medicinal product intended for submission to a regulatory organization is required to follow good clinical practice guidelines. Standards are enforced by periodic inspection by government officials of the country where the trials are to be carried out. Therefore, good clinical practice (GCP) training is important so your organization can comply with the industry and government good clinical practice guidelines, 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 GCP training available. Our comprehensive curriculum of online and public 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. 


Good Clinical Practice (GCP) Highlights

WHAT ARE GOOD CLINICAL PRACTICES (GCP)?
Good Clinical Practice (GCP) - An international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials involving human subjects that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.

Good clinical practice guidelines are regulations on how clinical trials should be conducted; they define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and clinical research associates.


Browse other GCP Training
Courses-click here or scroll down.
  

WHO IS INVOLVED IN GOOD CLINICAL PRACTICES (GCP)?

  • Coordinating Committee
  • Legally Acceptable Representative
  • Coordinating Investigator
  • QA/QC
  • Contract Research Organization (CRO)
  • Regulatory Authorities
  • Impartial Witness
  • Sponsor
  • Independent Data Monitoring Committee (IDMC)
  • Sponsor-Investigator
  • Independent Ethics Committee (IEC)
  • Subinvestigator
  • Institutional Review Board (IRB)
  • Trial Subject
  • Investigator

 

WHEN AND WHERE CAN I GET GOOD CLINICAL PRACTICE (GCP) TRAINING?

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


Course TitleScheduled
ADME Fundamentals 
Adverse Drug Event Monitoring and Reporting 
Analytical Methods Validation for FDA Compliance
Auditing and Inspecting Clinical Research in the Global Environment 
Biostatistics for the Non-Statistician - Beyond the Basics 
Clinical Studies for Medical Devices 
CMC Submissions in CTD Format
Combination Product Development: Safety/Registration/Approval 
Complaint Systems - The Essential Requirements
Conducting Effective Quality Audits
Design Control and Product Validation
Developing Specifications for Drug Substances (APIs) and Drug Products 
Documentation Management and Control
Early Stage Clinical Studies for Drugs and Devices 
Generic Drug Approvals
Good Clinical Practices (GCP) 
INDs/NDAs/CTDs
Introduction to Drug Delivery Technology 
Monitoring of Clinical Drug Studies 
Outsourcing Clinical Development 
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  

Other 'Good Practice' systems, aimed at providing reliable and quality work exist: Good Laboratory Practices (GLP) for laboratories conducting non-clinical studies; Good Manufacturing Practices (GMP) for the control and management of manufacturing and quality control testing of pharmaceutical products; 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
Active Pharmaceutical Ingredients
ADME Fundamentals 
Adverse Drug Event Monitoring and Reporting 
Analytical Methods Validation for FDA Compliance
Annual Product Reviews (APRs) For Pharmaceuticals 
Applied cGMPs for Pharmaceutical and Allied Industries 
Auditing and Inspecting Preclinical Research for GLP Compliance 
Auditing for cGMP 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 
cGTP in a Nutshell
Change Control/Deviation 
Choosing Sensors, Monitors and Instruments for PAT Programs
Clean Room Technology 
Commissioning, Qualification and Validation 
Complaint Systems - The Essential Requirements
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 (APIs) and Drug Products 
Developmental and Reproductive Toxicology 
Documentation Management and Control
Drug Product Stability and Shelf-Life
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 
Environmental Control and Monitoring 
Equipment Qualification in a Nutshell
Excipient GMPs 
FDA Drug Development and Compliance
Generic Drug Approvals
GLP Study Director 
GMP for Dietary Supplements 
GMP/QSR/QSIT for Medical Devices 
Good Distribution Practices 
Good Laboratory Practices (GLP) 
ICH Q10: Pharmaceutical Quality System 
ICH-Q7
Introduction to Drug Delivery Technology 
IQ, OQ, PQ
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Labeling OTC Drugs 
Laboratory Control System 
Medical Device Regulatory Compliance 
Microbiological Control and Validation 
Non-Clinical Drug Safety Evaluation and Drug Development 
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 

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