📅 Cleaning Validation Training - 17–18 Jun 2026. Limited seats. Reserve My Seat →
GMP Training Course

Cleaning Validation Training

Instructor-led training in pharmaceutical cleaning validation - MACO calculations, acceptance criteria setting, EU GMP Annex 15 compliance, sampling methodology, and validation protocol writing. Online and on-site delivery.

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Online & On-Site English & Arabic Jordan, UAE, KSA, Egypt & MENA Certificate of Attendance
Course Modules

What this training covers

A practical, regulation-aligned curriculum designed by PHARPRO consultants with 10+ years of inspection experience.

Module 1

Cleaning Validation Fundamentals

  • Why cleaning validation matters for GMP
  • Regulatory expectations (EU GMP, FDA, WHO)
  • EU GMP Annex 15 requirements overview
  • Worst-case product selection rationale
Module 2

Acceptance Criteria & MACO

  • What is MACO and how to calculate it
  • 10 ppm, 0.1% dose, and visual criteria
  • Health-Based Exposure Limits (HBELs)
  • Permitted Daily Exposure (PDE) principles
Module 3

Sampling Methods

  • Swab sampling - technique and documentation
  • Rinse sampling - when and how to use
  • Visual inspection as acceptance criterion
  • Sampling location justification
Module 4

Validation Protocol & Report Writing

  • Cleaning Validation Protocol structure
  • Acceptance criteria documentation
  • Test execution and data recording
  • Cleaning Validation Report requirements
Module 5

Ongoing Monitoring & Review

  • Cleaning effectiveness monitoring
  • Periodic cleaning validation review
  • Change control impacts on cleaning validation
  • Common inspection observations
Register

Reserve your seat - Cleaning Validation Training

17–18 June 2026. Fill in your details below and we will confirm by WhatsApp or email within hours, and send pre-reading materials before the session.

17–18 June 2026 · Limited Seats
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FAQ

Cleaning validation training questions

MACO (Maximum Allowable Carryover) is the maximum permitted residue from a previous product in the next batch. It is calculated using the safety-based approach (TTC/PDE) or the dose-based approach (10 ppm / 0.1% of therapeutic dose) - whichever is more stringent. The training covers MACO from first principles with worked examples for solid oral and sterile product scenarios.
Swab sampling wipes a defined area and analyses the swab for residue - preferred for direct surface testing and hard-to-clean areas. Rinse sampling collects the final rinse solvent for analysis - suitable for large or inaccessible surfaces but subject to dilution effects. The training covers when to use each, swab recovery studies, and acceptance criteria for both.
EU GMP Annex 15, EU GMP Annex 1 (2022 sterile manufacturing cleaning), FDA cleaning validation guidance, ICH Q7 (API cleaning), and WHO Technical Report Series guidance on cleaning validation.
Yes - the training covers EU GMP and FDA expectations for dedicated equipment: when to dedicate (highly potent compounds, allergens, sterile products), how to document the decision, and how it impacts your cleaning validation strategy.
QA managers, validation engineers, production supervisors, and regulatory affairs professionals responsible for cleaning validation programmes in pharmaceutical manufacturing - solid oral and sterile product environments.
Yes to all three. Online sessions are live and instructor-led. On-site delivery at your facility incorporates your equipment list and product matrix. Arabic-medium private sessions are available for teams across Jordan, Saudi Arabia, UAE, Egypt, and the wider MENA region.
A PHARPRO Certificate of Attendance documenting course title, content summary, delivery date, and instructor credentials - suitable for GMP training files and regulatory inspection review by FDA, EU GMP, WHO, or JFDA.