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Course Descriptions

21 CFR 111 Dietary Supplement GMP Overview
21 CFR 111 Dietary Supplement GMP Overview - Intro
21 CFR 117 for the Dietary Supplement Industry
21 CFR 121 Food Defense Plans for the Dietary Supplement Industry
21 CFR 121 Food Defense Plans for the Dietary Supplement Industry
510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
A-Z of Sterile Products Manufacture (in-person)
A-Z of Sterile Products Manufacture (virtual)
Active Substances and Excipients
Advanced Therapy Medicinal Products Training
Adverse Events and Product Quality Complaints - A Guide for Employees
AI Act, MDR/IVDR, QMSR: Practical AI compliance trainings for medical devices
AI in Medical Devices - Expectations in a Maturing Field
Analysis and Testing
Analysis and Testing
Auditing QC Laboratories Training
Batch Production Record (BPR) and Master Manufacturing Record (MMR)
Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
Botanicals Identification and Testing Course
CAPA Considerations: A Comprehensive Overview
Certificate in Pharmaceutical Manufacturing (5 Course Bundle)
Certified Investigator Training
Change Control Overview
Change Management in Practice - Selected Practical Examples for Evaluating Changes
Changing GMP Behaviors Training
China Registration - Approval for Medical Devices in China
Cleaning Qualification
Cleaning Validation Training
Cleaning, Sanitation and Contamination Prevention – Equipment Cleaning
Cleaning, Sanitation and Contamination Prevention – General Cleaning
Clinical Evaluation of Medical Devices - According to Regulation (EU) 2017/745
Clinical Investigation of Medical Devices - According to Regulation (EU) 2017/745
Combination Products GMP and Regulatory Overview (1.5 hours)
Computerised Systems Validation
Corporate In-House Training for Health Sciences
Course 1 Data Integrity: Overview and Documentation Completion, Review and Approval
Course 2 Data Integrity: Beyond the Basics
Course 3 Data Integrity: Management Requirements
Cybersecurity for Medical Devices - Understanding Regulatory Requirements and Applying Best-Practice Approaches
Data Integrity - A Series of Our 3 Courses
Data Integrity Introduction
Data Integrity Training
Deciding When to Submit a New 510(k) for a Change to an Existing Device (1.5 hours)
Design Controls for Medical Devices and IVDs
Design Controls for Medical Devices and IVDs (4 hours)
Designing Quality Into New Products To Win in the Marketplace
Deviation and CAPA Management Training
Deviation Investigations and CAPA Overview
Dietary Supplement Claims Substantiation
Dietary Supplement Labeling Compliance
Documentation Simplification Training
Drug Substances and Vendor Management
Enhancing Investigations with Human Factor Insights
Entering the Dietary Supplement Market as a Start-up – Facility Design for GMP Compliance
Entering the Dietary Supplement Market as a Startup - Product development, Planning for Regulatory Compliance
Equipment Qualification and Process Validation
EU IVDR Internal Auditor Training
EU MDR Article 15 (PRRC) - Rights and Responsibilities of the Person Responsible for Regulatory Compliance
EU MDR Internal Auditor Training
European Union In-Vitro Diagnostic Device Regulation (EU IVDR) (2 hours)
European Union Medical Device Regulation (EU MDR) (2 hours)
European Union Medical Device Regulation 2017/745: Technical Documentation (2 hours)
Facilities and Equipment
FDA Inspection Readiness (5 Course Bundle)
FDA Inspection Readiness for Dietary Supplements
FDA Inspections - Preparation, Support, and Follow Up for FDA Inspections
FDA Medical Device QS Regulation and Inspection Technique (QSIT) (2 hours)
FDA Medical Device Reporting Requirements (1.5 hrs)
FDA QMS Regulation 21 CFR Part 820 (1 hour)
Food Safety Modernization Act (FSMA)
Food Safety Modernization Act (FSMA) 21 CFR 117 for Dietary Supplements
Food Safety Plans and Hazard Analysis for the Dietary Supplement Industry
Foreign Supplier Verification Programs for the Dietary Supplement Industry
Formulation and Processing (Part 1 - Non-sterile Products)
Formulation and Processing (Part 2 - Sterile Products)
FSMA Supply Chain Programs for the Dietary Supplement Industry
Fundamentals of Biostatistics in Clinical Studies of Medical Devices - Learn to Convince with Statistical Significance
General Drug or Pharmaceutical cGMP and Quality Systems Program
Global Medical Device Regulatory Requirements - Brazil (2 hours)
Global Medical Device Regulatory Requirements – Australia (2 hours)
Global Medical Device Regulatory Requirements – Canada (2 hours)
Global Medical Device Regulatory Requirements – China (2 hours)
Global Medical Device Regulatory Requirements – Japan (2 hours)
Global Medical Device Regulatory Requirements – United States (2 hours)
GMP Essentials for Virtual Companies: Ensuring Compliance
GMP for Biological and Biotechnology Products
GMP for Clinical Trials Manufacture and Supply
GMP PQS Lead Auditor (CQI & IRCA Certified Training) (in-person)
GMP PQS Lead Auditor (CQI & IRCA Certified Training) (virtual)
GMP Refresher Training 2025
GMP's for Dietary Supplements - 21 CFR 111 Subparts B, C and D (Module 2)
GMP's for Dietary Supplements - 21 CFR 111 Subparts E, K, F & J (Module 3)
GMP's for Dietary Supplements - 21 CFR 111 Subparts G, L, M, N, O & Compliance (Module 4)
GMP's for Dietary Supplements - 21 CFR 111: GMP Overview and Subparts A, P, H & I (Module 1)
GMPs for Dietary Supplements: 21 CFR 111 Comprehensive Overview Bundle
Good Clinical Practice
Good Distribution Practices
Good Manufacturing Practices (GMPs) for Cosmetics
Good Manufacturing Practices for Natural Product Producers
Good Pharmacovigilance Practice Training
GxP Inspection Management Lifecycle
GxP Refresher: ICH Q8, Q9 and Q10
Health Software - Requirements of IEC 82304 1 - General Requirements for Product Safety
How to Develop an Effective Pharmaceutical Contamination Control Strategy
Interface of GMP with GCP Quality Management Systems 2025
Internal Auditing for Dietary Supplements
Internal Auditor Training
Internal Auditor Training Based on U.S. FDA 21 CFR Part 820
Internal Audits According to ISO 19011 for Medical Device Manufacturers and Their Suppliers
Introduction to Advanced Therapy Medicinal Products Training
Introduction to Product Labeling
Introduction to Product Labeling of Dietary Supplements
Introduction to Validation Course Bundle
Introduction to Vendor Qualification
Investigational Medicinal Products
ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes (2 hrs)
ISO 13485:2016 - Fundamentals - Medical Devices - QMS - Requirements for Regulatory Purposes
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
ISO 14971:2019 - Application of Risk Management to Medical Devices (2 hours)
ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application
ISO 17025 General Requirements for Testing and Calibration Laboratories (2 hrs)
ISO 18562: Biocompatibility of Breathing Gas Pathways
ISO 19011:2018 - Applying Principles to Medical Device QMS Audits
ISO 9001:2015 – An Overview and Changes
IVDR - Regulatory Requirements of Regulation (EU) 2017/746 and Practical Implementation
Labeling of Medical Devices - What Requirements Must Manufacturers Comply With
Laboratory Controls - Chemistry
Laboratory Controls - Microbiology
Mathematics and Statistics
MDSAP Internal Auditor Training
Medical Device Advertising and Promotion - FDA's Framework (1.5 hours)
Medical Device Complaint Handling and Servicing (1.5 hours)
Medical Device Consultant According to §83 MPDG: Legal Foundations, Responsibilities, and Practical Application
Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
Medical Device Single Audit Program (MDSAP)
Medical Device Software - Product Lifecycle Processes
Medicinal Chemistry and Therapeutics
Microbiology: The Basics
Module 1: An Introduction to Supplier Management
Module 2: Supplier Selection and Qualification in Supplier Management
Module 3: Documentation in Supplier Management
Module 4: Risk Management in Supplier Management
Module 5: Managing Supplier Client Relationships
NDI and GRAS Notification Training
Non-GMO Project Verification Training for Dietary Supplements
NSF Medical Devices Summit 2026
NSF Pharma Biotech Conference 2026
NSF Training Frequently Asked Questions (FAQ)
NSF/ANSI 455-2 Good Manufacturing Practice for Dietary Supplements Standard
Packaging and Labelling
Past, Present and Future - 20 Years of the QP Alumni
Pharmaceutical GMP
Pharmaceutical Law and Administration (in-person)
Pharmaceutical Law and Administration (virtual)
Pharmaceutical Legislation Update Subscription Service
Pharmaceutical Microbiology
Pharmaceutical Microbiology
Pharmaceutical Packaging
Pharmaceutical Qualified Person (QP) Training
Pharmaceutical Quality Systems (in-person)
Pharmaceutical Quality Systems (virtual)
PMCF Under the MDR: From Strategy to Successful Implementation
Post Market Performance Follow-Up (EU IVDR PMPF) (1 hr)
Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017 745)
Post Market Surveillance in the MDR Era - Building a Robust PMS System
Practical Module Training
Premarket Notification - FDA: Preparing a Premarket Notification (510(k))
Preparing for FDA Medical Device Inspections - Practical Guidance
Process Validation - Validation of Processes and Software Used in Production and Quality Systems
Process Validation and Equipment Qualification
Production Systems - Non-Sterile Drug Products
Production Systems - Sterile Drug Products
Production Systems-Biological Drug Products
QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
QMS Technical Writing Course for Dietary Supplements
QP Seminar for Prospective QPs and Sponsors
QP Seminar for Prospective QPs and Sponsors
Quality Management for Medical Device Manufacturers under MDR/IVDR and EN ISO 13485
Quality Management System Regulation (QMSR) - It's NOT Just ISO 13485!
Quality Risk Management
Quality Risk Management for Sterile Products Training
Quality Systems
Registration Types and Regulatory Requirements for the Asia Pacific Region
Regulatory Affairs for QA: Marketing Authorizations Training
Regulatory Affairs for QA: Variations Training
Requirements of Regulation (EU) 2017/745 (MDR) - Understanding and Implementing the Core Obligations
Responsible Person and Good Distribution Practice (Cogent Gold Standard Approved Training)
Risk Management and Design Controls for Medical Devices and IVDs
Risk Management Systems - Successfully Implementing the Requirements of ISO 14971 and MDR/IVDR
Root Cause Analysis: Investigative and Justification Writing for the Dietary Supplement Industry
Self-Inspections – How to Make Them Add Value to Your Organisation
SOP and Recordkeeping
SOP Writing and Revision
Statistical Methods in Quality Assurance - AQL According to ISO 2859‑1 and ISO 3951‑1
Statistical Process Control Training
Statistical Testing Training
Sterile Manufacturing Practices
Supplier Quality Management Series (5 Course Bundle)
Supplier Quality Management Training
Technical Documentation Academy — EU MDR and EU IVDR
Technical Documentation for Medical Devices
Technical Writing
The Future of the FDA - How Medical Devices Are Regulated in the U.S.
The Role and Professional Duties of the Qualified Person (in-person)
The Role and Professional Duties of the Qualified Person (virtual)
Understanding Top Management Responsibilities for Medical Device Quality Management Systems (1.5 hours)
US FDA Presubmission Program – Requesting FDA Feedback (2 hours)
Usability Engineering According to DIN EN 62366 1: Ensuring the Safe Use of Medical Devices
Vendor Qualification and Audit Training
Vigilance Under the EU MDR - Legal Foundations and Practical Application
Writing Effective Nonconformity Statements During Medical Device QMS Audits
Writing Effective Nonconformity Statements During Medical Device QMS Audits (30 mins)

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