Cleaning validation landscape from start to end
- Cleaning design and processes
- Type and selection of cleaners
- Soil residue evaluations (Worst Case selection)
- Determination of the critical parameter (SMART objective)
- Sampling selection based on a risk-based assessment
- Cleaning documentation life cycle
Cleaning Validation Concepts
- Introduction of relevant Guidelines
- CV Concepts
- CV Risk Management
- CV Plan
- CV Report
- CV Revalidation, CV Verification
- Typical inspection findings, warning letters
Cleaning Validation in Biotech API Plants
- What is different between chemical and biotech APIs?
- Acceptance criteria for biotech APIs
- What is the adequate analytical method to detect biotech APIs in cleaning validation
Special Aspects of Cleaning Validation
- Acceptance criteria
- Cleaning methods: CIP, WIP, manual cleaning
- Random Controls
- Hold time studies: DHT, CHT
- Validation of analytical methods used for CV
Cleaning Evaluation and Validation in Chemical API Production
- Differences regarding cleaning in API production to the production of medicinal products
- The challenges of API production
- Acceptance criteria
- Adequate sampling
- Is cleaning evaluation accepted by GMP?
Technical and Organisational Aspects on Equipment Regarding Cleaning Procedures
- Design and material aspects
- Requalification
- CIP aspects
- Riboflavin test
- Maintenance
How to write a Cleaning Validation Protocol
- Team and project validation creation (benchmarking best practice)
- GMP requirements and best practice for a protocol redaction and content
- Quality attribute to be tested for non- and sterile manufacturing
- Sampling and analysis methods overview
- Examples through a case study – validation and implementation in routine
4 Parallel Workshops
4 Parallel workshops, concentrating on medicinal products, chemical and biological manufactured APIs, and about the organisation of cleaning validation guarantee the practical orientation.
Please choose your workshop when registering.