Method Validation Course Pro APP – 1-year Licence

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Method Validation Course Pro™ – ICH Q2(R2) & Q14

An interactive course on analytical method validation: 25 lessons, 9 verified statistical tools, a final exam and a certificate. Built on ICH Q2(R2) and ICH Q14. Runs in your browser.

ACCESS Method Validation Course Pro™

1.Follow the link: https://method-validation-course-pro.vercel.app

2. Enter the access key provided with your purchase.

(This grants you a full 12 months of access to the application).

Validate it once. Defend it for years.

Most validation problems do not start at the bench. They start in the protocol: a characteristic nobody asked for, an acceptance criterion copied from the last method, an r value where a residual plot was needed. They come out months later, when an auditor asks a question the report cannot answer.

Method Validation Course Pro™ is an interactive course that takes you from a one-line statement of what the method is for, through every validation characteristic, to a report that holds up in an inspection. It then goes on to transfer, verification and revalidation.

What is inside

25 lessons in 6 parts: Foundations & the Lifecycle, Specificity & Range, Accuracy & Precision, Robustness, SST & Stability, Statistics That Survive an Audit, and Protocol, Report & Lifecycle.
The 20-second version at the top of every lesson: what is happening, the one thing worth memorising, and what to do at the bench.
“The auditor asks” in every lesson: the question an inspector would ask, and the answer that holds up.
9 statistical tools, each checked against published reference values: validation planner, linearity & residuals, DL & QL, accuracy & recovery, intermediate precision by ANOVA, total error interval, Grubbs outlier check, TOST equivalence and a Plackett–Burman robustness screen.
12 figures that show what a table of numbers hides.
A validation dossier on your dashboard that fills as you complete the lessons.
Reference & cheat sheet: the course in twelve lines, a go / no-go checklist, a symptom-to-fix table and a glossary.
Final exam and certificate: 24 questions drawn from a bank of 48, marked on the server. 80 % to pass, then a printable certificate of completion.

Who it is for

Analytical chemists writing or executing validation protocols
QC analysts and supervisors who review validation data
QA reviewers who approve protocols and reports
Scientists preparing for a method transfer or an inspection
Anyone moving into a validation role who wants the reasoning, not just the template

How it works

It is a web app, not a download. After purchase you receive a licence key by email. Open the course in your browser, paste the key and you are in. Nothing to install and nothing to update.

12 months of access from the date of purchase
2 devices, for example your work computer and your home computer
Move to a new computer yourself with Use on another device - no need to contact anyone
Works in Chrome, Edge, Safari and Firefox, on a computer, tablet or phone

Built on the current guidance

ICH Q2(R2) and ICH Q14, with ICH M10 for bioanalytical methods and USP <1224>, <1225> and <1226> for transfer, validation and verification.

About the author

Created by Mirela Gorjanu, a pharmaceutical analytical scientist working in method development, validation and regulatory compliance, and the author of the Practical Pharma Science™ courses and tools.

Method Validation Course Pro™ is an educational training tool. It is not a validated computerised system and does not produce a controlled GxP record. Every validation decision is made by qualified people under your quality system.

Licence terms

One licence = one person, 12 months, 2 devices.
A new device is confirmed with a code sent to your purchase email.
Please do not share your key: sharing is detected and the key may be disabled.

Frequently asked questions

Is this a download?

No. It is a web app you open in your browser with your licence key. There is nothing to install.

How long do I have access?

12 months from the date of purchase.

Can I use it at work and at home?

Yes. The licence covers 2 devices. If you replace a computer, free the old slot with “Use on another device”.

Does my progress move between devices?

No. Progress is saved in the browser you use, so do most of the course on one device.

Can I use the tools on my real validation data?

You can use them to learn and to cross-check your calculations. Formal results for a protocol or report must come from your validated systems.

Is there a certificate?

Yes. Pass the final exam (80 %) and you can print or save a certificate of completion as a PDF.

I did not receive my key.

Check your spam folder first. If it is not there, email practicalpharma.science@yahoo.com with your order number.

Buying for your lab or company?

Pay by card or PayPal and download a PDF invoice with your company name and VAT/tax number from your receipt. Need an invoice before you pay, a purchase-order reference, or licences for 5 or 10 analysts? Email practicalpharma.science@yahoo.com with your company name, billing contact and number of users, and you'll receive a quote within one business day.

HPLC, LCMS & GCMS Apps Suite Presentation

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