Current Requirements for Cleaning Validation
Current Requirements for Cleaning Validation
Cleaning Validation Courses
Validation of cleaning procedures is critical for any cleaning programme as defined in the current GMP Guidelines (Annex 15, Section 10): "Cleaning Validation should be performed in order to confirm the effectiveness of a cleaning procedure for all product contact equipment"
Since the first statement regarding cleaning in the GMP Regulations, the number of guidelines has greatly increased, especially since 2000. This has coincided with the increased focus by regulators within this area.
This course covers topics such as the development of regulatory expectations, effective cleaning procedures, processvalidation and control of these procedures. It will cover all areas from the inception of a cleaning strategy and policy through the development and performing of the exercise to the maintenance of the validated cleaning regimes.
For those new to this area, this course provides a detailed and structured introduction to cleaning validation, whilst for those who have been working in the field for some time this up to the minute course will provide details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. 50% of the course will be spent in lectures and the remainder will be spent performing practical exercises and in interactive workshops. It will cover subjects such as development of regulatory expectations, effective cleaning procedures and disinfectant regimes, development of effective cleaning techniques, interactive case studies and the validation and control of these procedures.
Who Should Attend This Course?
This course will be beneficial to new comers and experienced personnel from QC, Validation, Engineering, Production and QA.
Upon completing the course delegates will:
- Understand the key GMP requirements for cleaning validation and verification
- Understand the methods of cleaning including manual, automated or COP
- Be able to develop effective cleaning procedures
- Understand the significance of product development data in cleaning validation
- Develop approaches based on scientific rationale
- Develop protocols, define worst case locations, set limits and define acceptance criteria
- Apply best practice techniques for direct surface sampling and recovery
- Understand the suitability and technology associated with specific and non specific analytical techniques
- Apply risk assessment techniques
- Understand the importance of maintaining the validation state: cleaning stability studies and change control
The course will cover the following:
- Basics and Approach
- Acceptance Criteria
- Annex 15 Requirements for PDE
- Sampling and Recovery Analysis
- Rapid Equipment Cleaning Verification
- Monitoring Using TOC Analysis
- Practical Workshops
- Stability and Change Control
- Risk Based Approach to Cleaning Validation and Cross Contamination
- Case Study Workshop
- Discussion of Workshop Case Study
- Interactive Risk Assessment Session
- Maintenance and Disinfectant Efficacy Status
- Questions and Answers
Course Dates / Costs Description
Please see the table above for the dates of next courses and the costs.
Please note: Our online booking system works in £GBP. The € Euro price is a guide price only. The final € Euro amount payable online will be the current exchange rate of the £GBP amount.
If you wish to raise a purchase order or pay via any other means than Credit Card for a booking then these € Euro guide prices will prevail as being the booking cost despite any fluctuation in exchange rates.
Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.
Course Terms & Conditions
The Honeyman Group has trained thousands of people within the pharmaceutical industry. Our courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations and case studies to put these principles into practice.
All of our courses are delivered by experts who actively work within the pharmaceutical, biopharmaceutical and medical device industries, therefore, we will continue to share pragmatic current best practice advice to enable you to meet current GMP and regulatory expectations.
- Our speakers are active in the industry today and are able to provide up to the minute experiences and current best practice advice
- Accredited Specialist Training on selected courses in conjunction with Teesside University
- We can provide bespoke on site training, perfectly suited to deliver the most effective and relevant training
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