Course Catalog · Practitioner-Led
A catalog of cGMP training modules — fundamentals, documentation and data integrity, CAPA, process validation, cleaning validation, environmental monitoring, and complaint handling — scoped into a custom program for your team and taught by Jared Clark, CPGP, a consultant who implements cGMP systems for a living. Delivered on-site at your facility or as live virtual instructor-led sessions.
cGMP stands for current Good Manufacturing Practices — and the lowercase "c" is not decoration. It is the FDA's way of saying that compliance is a moving target. The agency expects manufacturers to use systems, technologies, and controls that reflect current regulatory thinking, not the state of the art from the year your SOPs were first written. A quality system that was perfectly adequate a decade ago can draw a 483 observation today, because the agency's expectations around data integrity, supplier qualification, and risk-based decision making have moved.
That single letter has a direct consequence for training. If expectations evolve, training has to evolve with them. A cGMP course that recites the text of 21 CFR 211 and stops there teaches your team the floor, not the standard they will actually be inspected against. Real cGMP training layers three things: the regulation as written, the guidance documents and enforcement trends that show how the FDA currently interprets it, and the practical habits — documentation discipline, deviation handling, honest investigations — that determine whether an inspection goes well.
That is the design philosophy behind every course in this catalog. The modules below are refreshed from active consulting work — real audits, real 483 observations, real remediations across 200+ client engagements — so what your team learns is what investigators are looking for now. For a deeper dive on the terminology, see cGMP vs. GMP: What's the Difference?
We don't sell one-size-fits-all seminars. The catalog below is a set of topic modules — you pick (or we recommend) the modules your team needs, and we assemble them into a custom program delivered on-site or live online. Pricing is scoped to your program — request a quote.
The foundation module for every role. What GMP is, why the "c" matters, the anatomy of a quality system, personal hygiene and gowning, contamination control, and the employee's role in product quality. Built around your product category's regulation — 21 CFR 210/211, Part 111, Part 117, or MoCRA/ISO 22716 — so operators learn the rules that actually govern them.
Good documentation practices (GDP), ALCOA+ principles, contemporaneous recording, error correction, and the data-integrity failures that dominate modern 483s and warning letters. Covers both paper and electronic records, audit trails, and the habits that make records defensible when an investigator reads them line by line.
Corrective and preventive action from trigger to effectiveness check: deviation and nonconformance handling, root-cause analysis methods that go deeper than "retrain the operator," risk-based prioritization, and writing CAPA records that demonstrate a functioning quality system rather than a paperwork exercise.
FDA's lifecycle approach — process design, process qualification, and continued process verification. What protocols and reports must contain, how to set acceptance criteria you can defend, and where validation programs most often fall apart under inspection questioning. Scoped to your processes, not generic examples.
Preventing cross-contamination with a defensible cleaning program: worst-case product selection, sampling methods (swab and rinse), acceptance limits and the science behind them, campaign versus product-changeover cleaning, and maintaining the validated state after the initial study is done.
EM programs for controlled environments: viable and non-viable monitoring, sampling site selection and justification, alert and action limits, trending, and — the part inspectors probe hardest — how you investigate and respond when an excursion happens. Relevant to sterile operations and any facility with classified areas.
Turning complaints into a compliant, useful signal: intake and triage, determining reportability, investigation depth proportional to risk, linkage to CAPA, and trending across products and lots. Includes the adverse-event and serious-event considerations specific to your product category.
Modules are starting points, not boundaries. Programs are regularly extended with supplier qualification, laboratory controls, change control, batch-record review, and inspection-readiness content — whatever your audit history and quality system call for.
Scope a Custom ProgramEvery module in the catalog can be delivered in any of three formats. The curriculum and documentation package are the same — the difference is where your team sits.
Training at your facility, on your lines, using your SOPs and batch records as the teaching material. Best for onboarding whole teams, inspection-readiness pushes, and any training where walking the floor makes the lesson concrete.
Instructor-led over video — fully interactive, real Q&A, same documentation package. Ideal for distributed teams, multiple shifts, and multi-site companies. See how online training works →
Annual training plans, refresher curricula, and role-based tracks built around your quality system and audit history — a program, not a one-off event. Combines on-site and virtual sessions as your schedule requires.
FDA regulations require training "as it relates to the person's functions" — which means one generic slideshow for everyone is exactly what the regulation is warning against. Programs are assembled per role:
cGMP fundamentals, hygiene and gowning, documentation practices, and how to recognize and report a deviation instead of working around it. The goal is operators who understand why the rules exist — because those are the operators who follow them when no one is watching.
Documentation and data integrity in depth, CAPA, complaint handling, batch-record review, and the quality unit's release responsibilities. QC staff add laboratory-facing content: sample handling, out-of-specification investigations, and defensible test records.
Validation topics, CAPA system ownership, trending and metrics, and managing the training program itself — including the records an investigator will ask to see. Managers also get the enforcement context: what recent 483s and warning letters say about where programs like theirs fail.
The regulatory "why": how cGMP requirements connect to enforcement, what management's responsibilities look like under FDA's quality-system thinking, and the decisions — resourcing, escalation, culture — that determine whether the rest of the training sticks.
Short answer: for training purposes, no — and anyone selling you a separate "cGMP course" and "GMP course" is selling the same course twice. cGMP is the FDA's term; the "c" signals that the agency holds manufacturers to current expectations, not a frozen reading of the regulation. "GMP" is the generic, international term — WHO, EU, and ISO frameworks all use it.
The distinction that does matter is between training that only recites the regulation and training that teaches current enforcement reality. A course can say "GMP" on the cover and be thoroughly current, or say "cGMP" and be a decade stale. Judge the content — and the person teaching it — rather than the label.
We wrote up the full history and the practical implications, including how the terminology differs across FDA, WHO, and EU frameworks, in cGMP vs. GMP: What's the Difference and Does It Matter for Training? More common questions are answered on our GMP training FAQ.
Every module is taught against the regulation that actually governs your product — not a generic composite. One instructor, four regulated industries.
21 CFR Parts 210/211 and API cGMP. Validation, laboratory controls, data integrity, and inspection readiness — the deepest track in the catalog, anchored by the instructor's CPGP credential.
Pharmaceutical GMP training →21 CFR Part 111 — identity testing, master manufacturing records, batch production records, quality operations, and the training requirement in §111.14 that inspectors check first.
Supplement GMP training →MoCRA has pulled cosmetics manufacturers into a GMP era many are unprepared for. Modules cover FDA's MoCRA-driven expectations alongside ISO 22716, the international cosmetics GMP standard most brands and contract manufacturers align to.
21 CFR Part 117 current GMPs — sanitation, allergen controls, personnel practices, and the Subpart A training and documentation requirements that apply to every covered facility, not just those with a full food-safety plan.
No two facilities need the same program, so we don't pretend they do. Scoping is a short, structured conversation — not a sales gauntlet.
Your product category, team size and roles, and what's driving the training — onboarding, an annual refresher cycle, an upcoming inspection, or findings from a recent audit. If you have a 483 or internal audit report, it becomes the syllabus's starting point.
We map modules to roles, propose session lengths and formats, and return a concrete plan with a quote scoped to your program — not a rate-card guess. You'll see exactly which module each role receives and why.
Sessions are delivered on-site or live online, each with knowledge assessments and completion certificates. You end with trained people and the attendance and assessment records an FDA investigator will ask to see — filed and inspection-ready.
Jared Clark — JD, MBA, PMP, CMQ-OE, CQA, CPGP, RAC
Jared is Principal Consultant at Certify Consulting and holds ASQ's Certified Pharmaceutical GMP Professional (CPGP) credential. He doesn't just teach cGMP — he implements it, with 200+ client engagements across pharmaceutical, supplement, cosmetics, and food manufacturing. His legal training adds the regulatory "why" that makes the "how" stick.
cGMP training teaches employees of FDA-regulated manufacturers how to follow current Good Manufacturing Practices — the regulations governing how drugs, supplements, cosmetics, and food are made, tested, documented, and released. The "c" stands for "current": FDA expects your systems and your training to keep pace with current regulatory thinking, not a snapshot from the year your SOPs were written.
In practice they are the same training. cGMP is the FDA's own term — the "c" emphasizes that manufacturers must use systems and technologies that are current, not merely compliant with the regulation as it read decades ago. A well-built GMP course is a cGMP course: it teaches the regulation plus FDA's current enforcement expectations. Full explainer here →
It depends on role and product category. Everyone needs cGMP fundamentals and documentation practices. Quality and production leadership typically add CAPA, complaint handling, and validation topics; sterile and controlled-environment operations add environmental monitoring. We scope module selection to your operations, your audit history, and the regulation that governs you — 21 CFR 210/211, Part 111, Part 117, or MoCRA/ISO 22716.
Pricing is scoped to your program — module selection, team size, number of sessions, and delivery format (on-site or live virtual) all affect the quote. Tell us about your team and your compliance timeline and you'll get a concrete, scoped quote rather than a generic rate card.
Yes. Every module in the catalog can be delivered as a live virtual instructor-led session with the same curriculum, interaction, and documentation package as an on-site workshop. FDA regulations require that training happen and be documented — they do not prescribe a classroom.
Tell us your industry, team size, and the modules you're considering. We'll recommend a program scoped to your operations — with a concrete quote, and every session documented for your training records.