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Training Areas
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Course Descriptions
- 21 CFR 111 Dietary Supplement GMP Overview
- 21 CFR 117 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
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- Analysis and Testing Training
- Applying ISO 19011:2018 Principles to Medical Device Quality Management System Audits
- Auditing QC Laboratories Training
- Australia Medical Device Regulations – A Comprehensive Overview
- Batch Production Record (BPR) and Master Manufacturing Record (MMR) Training
- Botanicals Identification and Testing Course - Part 1 and Part 2
- Brazil Medical Device Regulations – A Comprehensive Overview
- Business Continuity, Risk and Crisis Management
- Canada Medical Device Regulations – A Comprehensive Overview
- CAPA Considerations: Problem Statement Writing and Investigation Techniques
- Certified Investigator Training
- Changing GMP Behaviors Training
- China Medical Device Regulations – A Comprehensive Overview
- Cleaning Qualification
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- Cleaning, Sanitation and Contamination Prevention – Equipment Cleaning
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- Cleaning, Sanitation and Sanitary Design
- Computerised Systems Validation
- Corporate In-House Training for Health Sciences
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- CQI/IRCA-Certified QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements
- Customized Pharmaceutical Auditor Training
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- Deciding When to Submit a New 510(k) for a Change to an Existing Device
- Design Controls for Medical Devices and IVDs Overview
- Design Controls for Medical Devices and IVDs Training
- Designing Quality Into New Products To Win in the Marketplace
- Deviation and CAPA Management Training
- Deviation Investigations and CAPA
- Dietary Supplement Claims Substantiation
- Dietary Supplement GMPs Overview: 21 CFR 111 and Subparts A, P, H and I
- Dietary Supplement Labeling Compliance
- Documentation Simplification Training
- 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
- EU IVDR Internal Auditor Training
- EU MDR Internal Auditor Training
- European Union In Vitro Diagnostic Device Regulation (IVDR)
- European Union Medical Device Regulation – EU MDR
- FDA Inspection Readiness for Dietary Supplements
- FDA Presubmission Program – Requesting FDA Feedback
- Food Equipment
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- Food Safety Modernization Act (FSMA)
- Food Safety Modernization Act (FSMA)
- Food Safety Plans and Hazard Analysis for the Dietary Supplement Industry
- Food Science and Food Microbiology
- Foreign Supplier Verification Programs for the Dietary Supplement Industry
- FSMA Supply Chain Programs for the Dietary Supplement Industry
- Fundamentals of ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- General Drug or Pharmaceutical cGMP and Quality Systems
- GFSI Training: SQF, BRCGC, IFS and FSSC
- GMP for Biological and Biotechnology Products Training
- GMP for Clinical Trials Manufacture and Supply Training
- GMP for Engineers
- GMPs for Dietary Supplements: 21 CFR 111 Comprehensive Overview
- GMPs for Dietary Supplements: 21 CFR 111 Subparts B, C and D
- GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J
- GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
- Good Clinical Practice Training
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- Introduction to Advanced Therapy Medicinal Products Training
- Introduction to Product Labeling
- Introduction to Validation Training
- Introduction to Vendor Qualification
- Investigational Medicinal Products Training
- ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
- ISO 13485:2016 – Introduction to the Medical Device QMS Standard
- ISO 14971:2019 - Application of Risk Management to Medical Devices Overview
- ISO 14971:2019 Practical Application of Risk Management to Medical Devices
- ISO 17025 Testing and Calibration Laboratories
- ISO Standards
- Japan Medical Device Regulations – A Comprehensive Overview
- Mathematics and Statistics Training
- MDSAP Internal Auditor Training
- MDSAP Overview and Country-Specific Medical Device Regulations: Six-Course Bundle
- Medical Device CAPA Deviations and Writing Nonconformities
- Medical Device Complaint Handling and Servicing
- Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
- Medical Device Single Audit Program (MDSAP) Training
- Medicinal Chemistry and Therapeutics Training
- NDI and GRAS Notification Online Training
- Non-GMO Project Verification Training for Dietary Supplements
- On-Site and Customized Training
- Online Course on Writing Effective Nonconformity Statements During a Medical Device Manufacturer QMS Audit
- Packaging
- Pharmaceutical Auditor eLearning
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- Pharmaceutical Quality Systems eLearning
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- Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
- Practical Module Training
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- Statistical Process Control Training
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- Technical Documentation Academy – EU MDR and EU IVDR
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- The Role and Professional Duties of the QP Course
- The Roles and Responsibilities of an RP
- U.S. FDA Medical Device Inspections: What to Expect
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- U.S. Medical Device Quality System & Combination Products Regulations – Practical Instruction
- United States Medical Device Regulations – A Comprehensive Overview
- Vendor Qualification and Audit Training
- Webinars and eLearning
- Writing Effective Nonconformity Statements During a Medical Device QMS Audit
Our Experts
- Rick Andrew
- Ali Ardakani
- Deborah Baker-Janis
- Ahmad Bayat
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- Rod Wheeler
- Tom White
- Na Ry Woo
- Lisa Yakas
- Elvan Yalcin