Robert G. Schwarz
GXP-TrainCon
Referierende
New: with 2 interactive live Workshops!
Book the Main Course in combination with the Post-Course "Impact of Annex 1 Revision on Cleaning Validation" and save € 200!
Book the Main Course in combination with the Post-Course "Impact of Annex 1 Revision on Cleaning Validation" and save € 200!
Zielgruppe
The Main Course and the Post-Course are directed at staff of R&D, production and quality assurance involved in cleaning validation. They also address engineering companies and manufacturers of cleaning devices/equipment interested in learning more about the pharmaceutical industry’s viewpoint and in exchanging experiences.
Zielsetzung
Many questions relative to cleaning validation are still open and have to be answered within the companies:
- How should the cleaning validation concept look like to be GMP-compliant and cost-effective?
- Which risk analyses are applicable to cleaning Validation?
- How helpful can a riboflavin test be?
- Which maximum value is scientifically acceptable, especially in the field of APIs?
- Which sampling procedure is appropriate for which process and facility?
- How can you cut costs by means of bracketing?
- How are critical areas defined?
- Is cleaning evaluation the solution for seldom manufactured products?
- Which microbiological maximum values are valid in the areas of non-sterile dosage forms and APIs?
and
What are special aspects of cleaning validation in biotech/biologics plants?
These questions will also be discussed with the help of practical examples.
Background
In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection – Validation of Cleaning Validation Processes”, the PIC/S document PI 006 and Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7 “GMP for APIs” also requires cleaning validation – as well as two Guidelines by APIC, the association of European API manufacturers.
A Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 deal now with a PDE (Permitted Daily Exposure) approach.
The Annex 1 revision and it’s Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.
Programm
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) ensure interaction and that your questions are answered.
Five Q &A sessions (two on day 1 and on day 2 of the main Course) ensure interaction and that your questions are answered.
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
Book the Main Course in combination with the Post-Course "Impact of Annex 1 Revision on Cleaning Validation" and save € 200!
Conference language
The official conference language will be English.
The official conference language will be English.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Contact
Questions regarding content:
Mr Sven Pommeranz, +49 6221 84 44-47, pommeranz@concept-heidelberg.de.
Questions regarding Organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de.
Datum & Uhrzeiten
Tue, 27 April 2027, 09:00-17:00 h
Wed, 28 April 2027, 08:30-16:30 h
All times mentioned are CEST.
Wed, 28 April 2027, 08:30-16:30 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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