- Datum:
-
- Seminar
Cleaning Validation AND Post-Course: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Regulatory Requirements
- EU GMP Guideline Part I, II and III
- EU GMP Guideline Annex 15
- EMA “Shared Facilities Guideline” (incl. PDE concept)
- PIC/S PI 006
- APIC Cleaning Validation Guidance for APIs
- PDA TR 29 – “Points to Consider for Cleaning Validation
- ISPE Cleaning Validation Life Cycel – Applications, Methods, and Controls
- FDA 21 CFR 211.67
- FDA Guide to Inspection – Validation of Cleaning Processes
Practical Pre-Requisites I – Hygienic Equipment Design
- What is hygienic design?
- Material aspects
- WIP/CIP aspects
- Riboflavin test
Practical Pre-Requisites II – Cleaning Process Development
- Developing a cleaning process – which steps are necessary?
- TACT
- Which residues are common
- Type and selection of cleaners
- CIP vs WIP vs manual cleaning
- Cleaning Documentation
Sampling during Cleaning Validation
- How to define sampling points?
- Sampling techniques
- Swab
- Rinse
- Coupons
- Analytical requirements
Cleaning Validation – incl. Practical Approaches
- Cleaning Validation Concepts
- Bracketing
- Hold time studies (DHT, CHT)
- Cleaning Validation Risk Management
- Cleaning Validation Plan
- Cleaning Validation Report
- Cleaning Validation life cycle (Revalidation, Ongoing Cleaning Verification)
- Cleaning Evaluation
Workshop – Setting Sampling Points
- Setting sampling points on a risk-based Approach – what to consider
- Sampling point selection based on sampling technique and analytical method
- Different sampling points for different purposes
Handling Deviations and OOS during Cleaning Validation and Ongoing Cleaning Verification
- What is an OOS, what a deviation regarding Cleaning Validation?
- GMP-compliant documentation of OOS and deviations
- CAPA
Workshop – Case studies of Non-Conformities during Cleaning Validation and Ongoing Cleaning Verification
- Is always the cleaning process to blame?
- Which actions are adequate based on the Investigation and root cause?
- Actions depending on the time-point of detecting the Non-Conformity
- Does a Non-Conformity mean revalidation?
- Does a Non-Conformity always lead to Batch rejection?
Special Topics of Cleaning Validation
- Segregation & shared facility Guideline
- Cleaning Validation in Biologics & Biotech production
- Differences between chemical and biotech APIs
- Acceptance criteria for biotech APIs
- Analytical methods to detect biotech APIs in Cleaning Validation
Q & A sessions
Five Q &A sessions ( two on day 1 and on day 2 of the main Course and one during the post-course) ensure interaction and that your questions are answered.
Five Q &A sessions ( two on day 1 and on day 2 of the main Course and one during the post-course) ensure interaction and that your questions are answered.
Post-Course
With the Post-Course we cover:
- Regulatory requirements of Annex 1 regarding Cleaning Validation & Cleaning (incl. potential topics stated "between the lines")
- Annex 1, Annex 15 and EMA "Shared facilities Guideline" – harmonized, extended requirements or even contradictions!?
- Annex 1 & Cleaning Validation – practical approaches
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
