Robert G. Schwarz
GXP-TrainCon
Referierende
Book the Main Course in combination with the Post-Course Impact of Annex 1 Revision on Cleaning Validation and save € 200!
Zielgruppe
The Post-Course and the Main Course both 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
Main Training Course:
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 residue value is scientifically acceptable?
- 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 verification the solution for infrequently manufactured products?
- Which microbiological maximum residue 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.
Post-Course:
With the revised version of Annex 1 that became effective in August 2023, this course aims at giving you an overview of important changes that impact cleaning and Cleaning Validation which may not be seen at the first glance. As integral topic of the new Contamination Control Strategy (CCS), it will also be in the main focus of authorities during inspections of sterile medicinal products. Some of the strategies in Annex 1 may even become "state of the art" for non-steriles in the upcoming years. This is already explicitly mentioned in the scope of the new Annex 1. It will be elaborated how to align your Cleaning Validation strategy with this, highlighting points to consider when implementing those changes in requirements into your daily Cleaning Validation business.
With the revised version of Annex 1 that became effective in August 2023, this course aims at giving you an overview of important changes that impact cleaning and Cleaning Validation which may not be seen at the first glance. As integral topic of the new Contamination Control Strategy (CCS), it will also be in the main focus of authorities during inspections of sterile medicinal products. Some of the strategies in Annex 1 may even become "state of the art" for non-steriles in the upcoming years. This is already explicitly mentioned in the scope of the new Annex 1. It will be elaborated how to align your Cleaning Validation strategy with this, highlighting points to consider when implementing those changes in requirements into your daily Cleaning Validation business.
Background
Main Training Course:
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 its Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.
Post-Course:
The Annex 1 Revision of is in operation since 25 August 2023. The new Contamination Control Strategy (CCS) affects also the Cleaning Validation.
The Annex 1 Revision of is in operation since 25 August 2023. The new Contamination Control Strategy (CCS) affects also the Cleaning Validation.
Programm
Main Course
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
Weitere Informationen
Date
Main Course: Cleaning Validation
Tuesday, 27 April 2027, 09:00-17:00 h
Wednesday, 28 April 2027, 08:30-16:30 h
Main Course: Cleaning Validation
Tuesday, 27 April 2027, 09:00-17:00 h
Wednesday, 28 April 2027, 08:30-16:30 h
Post-Course: Impact of Annex 1 Revision on Cleaning Validation
Thursday, 29 April 2027, 09:00-12:30 h
All times mentioned are CEST.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online Meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Main Course: Cleaning Validation
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.
Post-Course: Impact of Annex 1 Revision on Cleaning Validation
ECA Members € 590
APIC Members € 690
Non-ECA Members € 790
EU GMP Inspectorates € 395
The conference fee is payable in advance after receipt of invoice.
We will offer you a discount of € 200 if you book both training courses together.
Conference language
The official conference language will be English.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. 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
Wed, 28 April 2027, 08:30-16:30 h
Thu, 29 April 2027, 09:00-12:30 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 2280,- |
| Non ECA Member*: | € 2680,- |
| EU/GMP Inspectorates*: | € 1240,- |
| APIC Member Discount*: | € 2480,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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E-Mail: info@concept-heidelberg.de
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