Comprehensive online regulatory training aligned with FDA regulations, 21 CFR, and ICH standards — trusted by US pharmaceutical, biotech, and generic drug professionals. Self-paced. 21 CFR Part 11 compliant certificates. Inspection-ready training records for FDA audits.
The U.S. Food and Drug Administration (FDA) enforces one of the most stringent and complex regulatory frameworks in the world for pharmaceuticals and biologics. The framework is built upon the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, with implementing regulations codified in Title 21 of the Code of Federal Regulations (21 CFR). US regulatory professionals must master the requirements for the full drug development lifecycle, including INDs, NDAs, BLAs, and ANDAs, all while adhering to ICH guidelines for global harmonization.
| Agency/Standard | Framework | Application |
|---|---|---|
| FDA | Federal Food, Drug, and Cosmetic Act | Statutory authority for drug regulation |
| FDA | 21 CFR Parts 200-499, 600-699 | Regulations for drugs, biologics, and devices |
| FDA | 21 CFR Part 312 | Investigational New Drug Application regulations |
| FDA | 21 CFR Part 314 | New Drug Application regulations |
| FDA | 21 CFR Part 601 | Biologics License Application regulations |
| ICH | ICH Guidelines (E, M, Q, S series) | International harmonisation for submissions |
All courses are self-paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during FDA inspections.
This comprehensive training is designed to provide pharmaceutical professionals with an in-depth understanding of the regulatory requirements for preparing and submitting Abbreviated New Drug Applications (ANDAs) to the FDA. It incorporates the latest developments under GDUFA III and covers the Hatch-Waxman Act, bioequivalence science, patent certification (Paragraph IV), and post-approval changes. This is the most critical course for the US generic drug industry.
Provides comprehensive knowledge of the planning, preparation, submission, and review of BLAs to the FDA. The program covers the full eCTD structure, CMC, nonclinical and clinical data, FDA review processes, and inspection readiness. This is essential for the booming US biotech sector.
Enroll in Biologics License ApplicationCovers the entire drug development and approval process, with a deep dive into each component of the New Drug Application (NDA) organized into the five CTD modules. This program is foundational for any professional in the US pharmaceutical industry involved in innovative drug development.
Enroll in Mastering the NDACovers the entire orphan drug development and approval process under the Orphan Drug Act of 1983. Participants learn the step-by-step process for obtaining orphan drug designation from the FDA Office of Orphan Products Development, including benefits like seven-year exclusivity and tax credits.
Enroll in Mastering the Orphan Drug NDAProvides a comprehensive end-to-end understanding of the IND framework as regulated by the FDA. This program covers the legal basis for the IND exemption, the detailed preparation of the initial IND package, the 30-day review timeline, and safety monitoring. It is critical for anyone involved in initiating clinical trials in the US.
Enroll in Regulatory Affairs SpecialistsComprehensive certification covering the global pharmaceutical regulatory landscape with a strong focus on the US FDA and ICH requirements. This program provides foundational and advanced strategic capabilities across all major application types (IND, NDA, ANDA, BLA).
Enroll in Regulatory Affairs TrainingRegulatory training is mandatory for all professionals involved in the research, development, manufacturing, and marketing of FDA-regulated products.
The FDA conducts inspections of pharmaceutical manufacturers, distributors, and logistics providers. Inspection findings can have serious consequences:
Common FDA GDP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that FDA investigators accept during inspections.
Canada joined the Pharmaceutical Inspection Co operation Scheme (PIC/S) — the international body that harmonises GMP and GDP standards across 55 member countries. This has direct implications for how GDP training is structured for Canadian professionals.
Health Canada GDP requirements are closely aligned with EU GDP and WHO GDP — meaning training that covers PIC/S harmonised GDP principles is relevant for Canadian professionals working in any international context.
Canadian facilities with Health Canada GDP certification are recognised by many international regulators. Our training covers the core GDP principles recognised by all PIC/S member authorities — including FDA, EMA, and WHO.
Canadian distributors supplying the US, EU, or other markets must meet multiple regulatory frameworks simultaneously. Our GDP courses cover all relevant frameworks in a single, comprehensive program.
Training your entire QA, warehouse, or transport team? We offer group enrollment for Canadian pharmaceutical logistics companies of all sizes. Group quotes provided within 24 hours.
| Feature | GxP Trainings |
|---|---|
| FDA 21 CFR Part 205 aligned | |
| FDA 21 CFR Parts 210 & 211 aligned | |
| DSCSA requirements covered | |
| DSCSA requirements covered | |
| PIC/S GDP Guide (PE 011 1) covered | |
| WHO GDP aligned | |
| ICH Q9 (Quality Risk Management) covered | |
| 21 CFR Part 11 compliant certificate | |
| Self paced — study on your schedule | |
| Instant certificate download | |
| Verifiable certificate ID | |
| Group / corporate enrollment |
The FDA does not pre-approve training providers but expects that personnel are adequately trained. Our 21 CFR Part 11 compliant certificates provide verifiable, auditable proof of training that is widely accepted during FDA inspections.
Under 21 CFR Part 314 and 312, records must be retained for specific periods, often for 2 years after approval or for the duration of the investigation. Our certificates provide permanent, traceable records.
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
All courses include lifetime access — study at your own pace, on your own schedule.
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Equip yourself and your team with the Regulatory Affairs knowledge and documented training records required for Health Canada, FDA, and WHO inspection readiness.