Biopharma Compliance GxP, HIPAA, SOC 2, FDA & Audits

Learn GxP, data integrity, Part 11, HIPAA, GDPR, and FDA audits through one company's complete compliance journey.
What you'll learn

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Understand how GxP, quality systems, data integrity, privacy and security, and regulatory oversight all fit together in biopharma compliance.
Apply GLP, GCP, GMP, GDP and GVP to real situations, and know who is accountable when a CRO, CDMO, or vendor gets something wrong.
Know when 21 CFR Part 11 and ALCOA+ rules actually apply, and assess computerized systems using risk-based CSA thinking.
Treat GxP, privacy (HIPAA, GDPR) and security (ISO 27001, SOC 2) as three separate questions, not one interchangeable checkbox.
Understand the FDA and EMA regulatory pathways from IND to BLA in the U.S. to the EU's centralised procedure, and know what each expects.
Recognize what actually happens during an audit or FDA inspection, from Form 483s to Warning Letters and recalls, through real cases like Ranbaxy and Teva.
Requirements

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No background in biopharma or compliance needed. Every regulation and acronym gets explained from scratch.
No special tools or software required. This is a story-driven course, not a technical tutorial.
Work in tech or SaaS but new to biopharma? This course was written for exactly that.
All you really need is curiosity about how heavily regulated industries actually work.
Description

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This course contains the use of artificial intelligence.
Biopharma Compliance: GxP, HIPAA, SOC 2, FDA & Audits
Most compliance courses teach GxP, HIPAA and ISO 27001 as a list of unrelated acronyms to memorize. This one doesn't.
Instead, you'll follow BioLife Pharma, a fictional biopharma company, as it takes a new biologic drug called BioCure from early lab research all the way to a patient's hospital bed. Every regulation you learn shows up exactly where it matters in that story: GLP when BioLife tests BioCure in the lab, GCP once real patients join clinical trials, GMP when the drug goes into manufacturing and GVP once it's already reached the market.
Underneath those checkpoints, you'll learn the quality system that actually makes them work (ICH Q9 and Q10, CAPA, change control, training and document control), what makes electronic records and computerized systems trustworthy (21 CFR Part 11, ALCOA+, CSV and CSA) and when GxP rules actually apply to a piece of software. If you're on the technology or vendor side, that last part alone answers the most common question you'll get from a biopharma customer's compliance team.
Privacy and security get their own real treatment too: HIPAA, GDPR, ISO 27001, and SOC 2 each explained as its own separate question, not just another item on the same checklist as GxP.
Along the way, you'll see five real companies that got parts of this wrong, and what it actually cost them: Ranbaxy's $500 million penalty, Teva's $519 million FCPA settlement, Anthem's $16 million HIPAA fine and FDA warning letters against Dabur India and Akorn. These aren't hypotheticals. They're what happens when the systems in this course don't hold up.
By the end, you'll have a full map of biopharma compliance, a keepable cheat sheet and the ability to actually reason through a compliance question you've never seen phrased quite this way before, instead of just reciting definitions.
Who this course is for

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Professionals moving into biopharma from another industry.
Engineers and product managers building software for biopharma or health-tech.
QA, RA and compliance professionals wanting practitioner-level fluency.
Life sciences or regulatory affairs students wanting real-world context.
Health policy or public health professionals curious how regulations get implemented.
Anyone curious how heavily regulated industries actually work.
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