SPEAKERS:

Dr Martina BreuerHaupt Pharma Münster GmbH

Walid El AzabSteris Cooperation, Belgium

Peter MungenastMerck

Dr Hermann J. PetersQLR Consultancy

15 - 16 April 2015, Munich, Germany

Cleaning Validation

With 3 Parallel Workshops

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This education course is recognised for the ECA GMP Certification Programme „Certified Validation Manager“. Please find details at www.gmp-certification.eu

LEARNING GOALS:

� APIs and Pharmaceuticals

� Concepts

� Cleaning validationplan and report

� Risk Management

� Pitfalls and findings in inspections/Warning Letters

� Cleaning Evaluation

� Is cleaning evaluation accepted by GMP

� Special Aspects of Cleaning Validation

� Validation of holding times

� Acceptance Criteria

� Technical Aspects

� Design and CIP Aspects

� Cleaning Validation in Biotech API Plants

� Workshop regarding biological manufactured APIs

NEW

Background

In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamina-tion. In compliance with the GMP regulations, cleaning is performed and documented according to the de-scribed procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are in-creasingly an issue in inspections and audits. The suc-cess of cleaning procedures has to be validated. In ad-dition to the FDA “Guide to Inspection of Cleaning Validation”, 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 manufactur-ers.A new Draft Guideline from EMA on Dedicated Facili-ties and Exposure Limits for Cleaning Validation and the Annex 15 draft now deal with a PDE (Permitted Daily Exposure) approach.

Learning Goals

Many questions relative to cleaning validation are still open and have to be answered within the companies:

� What does the cleaning validation concept have to 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

� Special aspects of cleaning validation in biotech API plants

These questions will also be discussed with the help of practical examples.

3 parallel workshops – concentrating on medicinal products, chemical and biological manufactured APIs – guarantee the practical orientation.

Please choose your workshop when registering.

Target Audience

This course is directed at staff of R&D, production and quality assurance involved in cleaning validation. It also addresses engineering companies interested in learn-ing more about the pharmaceutical industry‘s view-point and in exchanging experiences.Note: The number of participants is limited.

Accessories: Please bring along a pocket calculator.

Cleaning Validation

15-16 April 2015, Munich, Germany

Programme

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

Social Event

On 15 April you are cordially invited to a conference dinner. This is an excellent op-portunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Speakers

Dr Martina BreuerHaupt Pharma Münster GmbHMartina Breuer studied pharmacy at the University in Munster. She has more than 20 years experience in pharmaceutical industry and was employed in various positions in Quality control, Production

and in Quality assurance. Since 2008 she is Head of Quality assurance at the Aenova site in Munster responsi-ble for the quality system to be compliant with EU-GMP and CFR requirements.

Walid El Azab, Steris Cooperation, BelgiumWalid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently pro-vides technical support related to clean-ing chemistries, disinfectants and sterility

assurance products and their application and validation. His areas of expertise include both upstream and down-stream biopharmaceutical operation and validation. Walid has held various positions including Project Man-ager, Inspection Readiness Manager, Quality and Regula-tory Manager, and Qualified Person (QP). Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liege, Belgium and is green belt certified.

Peter Mungenast, Merck KGaAHe studied Biology and Chemistry at the University in Karlsruhe. Then he worked in different functions for Merck KGaA. Since 1996 in the Quality Assurance de-partment responsible for cleaning valida-

tion, training and different projects.

Dr Hermann J. PetersQLR Consultancy, Ulm Hermann Peters studied chemistry in Karlsruhe (Diploma), Philosophy in Mu-nich (B.A.) and Life Sciences at the Frank-furt University (PhD Life Sciences). He worked for more than 26 years in a Biop-

harmaceutical CMO focused on active substances from mammalian cell cultures and on aseptic filling. He estab-lished Quality Assurance and Regulatory Affairs, acting most time as Vice President Quality Assurance/ Regula-tory Affairs and finally as Senior Advisor. Since Dec. 2014 he is an independent consultant, founder and principal of QLR Consultancy.

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15 - 16 April 2015, Munich, Germany

Date

Wednesday, 15 April 2015, 10.00 h - 18.00 h(Registration and coffee 09.30-10.00 h)Thursday, 16 April 2015, 08.30 h - 15.30 h

Venue

Holiday Inn Munich -City CentreHochstraße 381669 Munich, GermanyPhone +49 (0)89 - 4803 0Fax +49 (0)89 – 448 7170

Fees (per delegate plus VAT)

ECA Members € 1,490APIC Members € 1,590Non-ECA Members € 1,690EU GMP Inspectorates € 845The conference fee is payable in advance after re-ceipt of invoice and includes conference docu-mentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reserva-tion is recommended. Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference Language

The official conference language will be English.

Organisation

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O.Box 10 17 64 69007 Heidelberg, Germany, Phone ++49-62 21/84 44-0Fax ++49-62 21/84 44 34info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Sven Pommeranz (Operations Director) at +49-(0)62 21 / 84 44 47, or per e-mail at pommeranz@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Mr Ronny Strohwald (Organisation Manager) at +49-(0)62 21 / 84 44 51, or per e-mail at strohwald@concept-heidelberg.de.

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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

wa/vers1/15052014

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