Course not currently available
Current Requirements for Cleaning Validation - x
Course
In Barnard Castle ()
Description
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Type
Intensive workshop
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Level
Intermediate
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Class hours
15h
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Duration
2 Days
Suitable for: The course will be beneficial for newcomers and experieinced personnel from QC, Validation, Engineering, Production and QA.
Important information
Documents
- Current_Requirements_for_Cleaning_Validation_V1.5.pdf
About this course
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.
This course will be beneficial to new comers and experienced personnel from QC, Validation, Engineering, Production and QA.
This course covers topics such as the development of regulatory expectations, effective cleaning procedures and the validation and control of these procedures. 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 time will be spent in lectures and 50% of the course will be spent performing practical exercises and in interactive workshops.
Reviews
Subjects
- Effective Cleaning Procedures
- Cleaning validation
- CGMP Expectations
- Risk Assessment
- Annex 15 Requirements
- Sampling and Recovery Analysis
- Rapid Equipment Cleaning Verification
- TOC Analysis
- Cross Contamination
- Disinfectant Efficacy
- Product contact equipment
Teachers and trainers (1)
Marcus Booth
Director of Training and Consultancy
Over the last 27 years we have trained thousands of people within the pharmaceutical, biotech, medical device and health care industries. Honeyman courses continue to remain popular because they provide delegates with a sound understanding of the scientific principles associated with each technical discipline and the opportunity to put the principles into practice during interactive workshops, demonstrations and discussion sessions. We all actively work within industry and so provide pragmatic current best practice to allow companies to cGMP requirements and regulatory expectations.
Course programme
Course review:
This course covers topics such as the development of regulatory expectations, effective cleaning procedures and the validation and control of these procedures. 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 time will be spent in lectures and 50% of the course will be spent performing practical exercises and in interactive workshops.
Current Requirements for Cleaning Validation - x