Presented by
Management Forum
Cleaning Validation Best Practice in Pharmaceuticals Training Course
Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.
5-6 December 2024
+ 8-9 April 2025, 8-9 July 2025, 2-3 December 2025 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Learn how to establish and implement efficient and effective cleaning processes to ensure your equipment and facility are properly cleaned and sanitised before pharmaceutical production.
Pharmaceutical products can be contaminated by other pharmaceuticals, cleaning agents, microorganisms, or various other factors. Such contamination poses significant and serious health risks to the public. To mitigate these risks, standards and guidelines on best practices for the pharmaceutical industry have been established. Cleaning validation is a widely used practice in the industry to ensure these standards are met.
Cleaning validation is essential for the pharmaceutical manufacturing process, ensuring that equipment is adequately cleaned to prevent contamination of subsequent products. Regular monitoring and evaluation of cleaning procedures are necessary to maintain consistent and acceptable performance. A robust management system should be in place to address changes, variations, and unexpected occurrences, ensuring reliable performance throughout the equipment's usage period.
This cleaning validation training consists of two distinct modules. The first day provides an overview, covering all aspects of cleaning validation. The second day delves into advanced topics, offering an in-depth exploration of specific issues crucial to understanding the current regulatory environment.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
Benefits of attending
- Expand your knowledge on international cleaning validation guidelines
- Enhance your strategies for validation protocols
- Understand how to prepare the cleaning validation protocol and report
- Learn monitoring, revalidation, and validation maintenance for validates processes
- Master cleaning methods, cleaning mechanisms, cleaning agents, equipment grouping and risk-based decision making
- Clarify the logic of audit findings
- Get-to-grips with utilising a life cycle approach to cleaning validation
- Identify how to select sampling methods and sites, as well as proper selection of blanks and control
Who should attend?
Professionals responsible for various aspects of cleaning validation, including:
- Validation scientists
- Validation service personnel
- Production engineers
- Quality assurance specialists
- Quality control technicians
- Analytical chemists
- Regulatory affairs professionals
- Pharmacologists
- Toxicologists
- Technical support scientists
- Supervisors, managers, and directors of groups supporting cleaning validation
This course will cover:
Cleaning validation defined
- Regulatory guidance and expectation for cleaning validation
- ICH Q7, EU GMP Annex:1, Annex:15, PI 006-3:2007
- ISPE, PDA, ASTM Guides
Definitions and documents needed
- Cleaning validation policy
- Cleaning validity master plan
- Cleaning validation protocol report
- Understandable cleaning validation SOP
- Design/development of a cleaning process
Calculations
- Principles and calculations of residue limits for a wide variety of residue types, routes of administration, and dosage types
- Non-uniform contamination
- Surface areas in carryover calculations
- Microbial criteria of cleaning validation
- Limits for "product X to product X"
- Biofilm formation and cleaning validation concerns
- DHT (dirty hold time), CHT (clean hold time) studies challenges
Analytical methods
- Selection of analytical methods, along with appropriate levels of analytical method validation
- Establish a soil library for a cleaning validation process
- Selection of sampling methods and sampling sites, selection of blanks and controls
- Selection of cleaning agents and cleaning mechanisms
- Robust recovery data
Health-based limits
- Rationale for health-based limits
- Biopharmaceutical cleaning validation approaches
- Establish permitted daily exposure (PDE)/ allowable daily exposure (ADE)
- Health-based approach to a possible chemical contamination
Critical process parameters and critical quality attributes
- Critical process parameters
- Critical quality attributes
- How to understand recovery studies
Group exercise - how to write a bulletproof cleaning validation protocol
- Critique of format
- Critique of content
Modes of cleaning
- Water quality for the state of the art cleaning validation
- CIP & COP Concerns
- Approaches for indirect-product contact surfaces
- Approaches for non-product contact surfaces
- Manual cleaning validation difficulties
- Most difficult to clean areas on a surface
Life-cycle approach to cleaning validation
- Utilizing a life cycle approach for cleaning validation
- How to manage protein inactivation and degradation in Biotech Cleaning Validation
Risk assessment concerns
- Robust risk assesment to manage a successful cleaning program
- What is Spray covering testing?
Training
- Personnel training and qualification on cleaning validation
- Swabbing Errors
- Visual cleaning and setting limits
Change control, revalidation, and continuous process verification
- Monitoring, change control, revalidation and validation maintenance for validated processes
- Using statistics in cleaning validation
Group exercise - how to perform a cleaning validation of a biopharmaceutical API?
Cleaning validation for medical devices
- How to validate the cleaning of medical devices
Case studies
- Health authority inspection citations
- Which questions should be asked during an audit?
Bad practices
- Case studies and lessons learned from a cleaning validation bad practices
- Dangers during cleaning validation implementation
Mustafa Edik
Mustafa Edik is an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
5-6 December 2024
Live online
09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 15320
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 31 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
8-9 April 2025
Live online
09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 15321
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 04 Mar
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
8-9 July 2025
Live online
09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 15322
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 03 Jun
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
2-3 December 2025
Live online
09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 15323
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 28 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
