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

19-21 March 2019, Vienna, Austria

SPEAKERS:

Dr Jean Denis MalletECA & Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS

Gert MoelgaardPast Chairman of ISPE, Senior Consultant

Markus MulthaufSenior Consultant GMP-Engineering

Stephan ReuterOptima Pharma

Dr Ingrid WaltherFormer Head of the Business Unit iv Drugs, Fresenius

GMPs for Equipment, Utilities and FacilitiesPharma Engineering for Pharmaceutical Companies and Suppliers

LEARNING OBJECTIVES:

� GMP-compliant Equipment Design � Requirements on Materials and Surfaces � GMP requirements for Cleanrooms, HVAC and Barrier Systems � Re-Construction and Renovation of Facilities � GMP-compliant Water Systems � Qualification, Re-Qualification and Commissioning � Technical Change Control � Maintenance & Calibration � Auditing of Technical Suppliers � Impact of the new GMP Thinking on engineering

Objectives

This course explains how the requirements laid down in the GMP and FDA regulations can be put into techno-logical and engineering practice. The whole lifecycle from the design, the qualification and the maintenance of equipment is covered. The new Annex 15 of the EU GMP Guide plays an important role here as well.

Background

Technical compliance is a wide field, especially when taking into account the ICH framework which covers the whole lifecycle of pharmaceutical manufacturing.It does not only mean to comply with regulatory guide-lines but also with submissions and the technological state of the art, meaning ISO and other standards as well as accepted good practices in the pharmaceutical indus-try.

In this GMP course we want to focus on the main topics with regard to compliance in the technical environment:

Technical QA aspectsThere are a number of quality assurance systems which are crucial for the technical units. Most important are changes and deviations (as they also can occur in techni-cal environment) which have or might have a direct im-pact on the pharmaceutical material produced. And even more important is the validation system, where the qualification of equipment, utilities and facilities has to be part of.

GMP Facility & Re-ConstructionDesigning an appropriate layout belongs to this part as well as understanding what the GMP requirements for the cleanrooms and for the HVAC systems are, depend-ing on the type of manufacture. Re-Construction during on-going manufacture is supreme discipline in this field.

GMP-compliant design of equipment A GMP-compliant design of equipment is the basis for fulfilling the technical requirements. In this respect, engi-neering assumes a prominent role in ensuring the safety of medicinal products. In this context, the need for mate-rial certificates is often subject to discussion.

Validation / QualificationNot only GMP regulations but also inspectors consider qualified equipment and validated processes as the pre-requisites for producing pharmaceutical quality. The identification of the equipment that has to be qualified by means of a risk analysis is a crucial point. This field has now re-gained considerable attention as the regulations are changing: After FDA’s new guide on validation (and process verification) also Annex 15 of the EU GMP Guide has been revised.

Routine OperationPreventive maintenance in pharmaceutical production is an essential element of the Pharmaceutical Quality Sys-tem. Systems for calibration & handling of repairs are of equal importance for maintaining the qualified state. That’s why maintenance and calibration are parts of an efficient requalification system, besides the change con-trol and deviations systems of course. Finally, auditing the own technical suppliers is a recurring activity from the beginning of a project until the outsourcing of engi-neering activities later on.

Target Audience

This course is directed at staff in pharmaceutical engi-neering departments, at technicians, engineers, planners as well as plant constructors and equipment suppliers who are involved in tasks related to engineering work in a cGMP environment.

Programme

QA systems with technical relevance

Part 1: Change Control, Technical Changes and Marketing Authorisations

� Regulatory Requirements � Identification of „Changes“ - What has to be handled

under Change Control? � CC Workflow and pitfalls � Change Management in Routine Operations vs.

Project work � Marketing Authorization - Regulatory Affairs for

Engineers

Part 2: Deviations, CAPA & Malfunctions � Deviations in the technical environment � Documentation in logbook and higher-level systems � Evaluation of technical deviations � When does a deviation require CAPAs? � Handling of alarms � Correlation between changes, deviations, repairs and

maintenance � Examples

Risk Analysis � Managing risks in the technical environment � Project risks � Equipment risks � Product risks � Risk management tools � Examples

GMPs for Equipment, Utilities and Facilities

19-21 March 2019, Vienna, Austria

Qualification, Re-Qualification & Commissioning � What to write in a URS & what not � Using risk analysis from kick-off to routine operation � Handling impact and non-impact systems � From URS to PQ: step by step � How to ensure traceability? � System Verification / Validation � Re-Qualification: How to..? And how often? � Examples

Materials and Surfaces � Which materials can be used and for what purpose? � Stainless steel, plastics, polymers,… � How smooth have surfaces to be? Roughness and

structures of cleanable surfaces � What are the requirements on welding? � Effects of corrosion, failures, and damage

GMP-compliant Equipment Design � Open and closed systems � Overview on important construction details for sterile

and non-sterile applications � Design of gaskets and problems with gaskets � Allowed lubricants � Valves � Pumps � Examples of GMP-compliant equipment

GMP Zone Concepts (sterile/non-sterile/highly potent) � Basic GMP requirements for materials & pharmaceuti-

cals handling � Physical requirements (areas) vs Dynamic require-

ments (HVAC) � Finding the correct requirements depending on the

manufacturing operation � Defining an appropriate layout and air lock concept � Defining personal & material flows � Product vs Personal Protection � Product Protection concepts, types of air flows � Avoiding Cross Contamination: the EMA idea � The future of barrier systems (isolator and RABS)

GMP Class Requirements (HVAC and Barrier Systems) � Some HVAC system concepts (e.g. fresh air /

recirculated air) � Understanding the main parameters (volumes,

pressure, cleanliness, etc.) � GMP Classification and ISO standards, and their

interaction � The basics of air filtration and flushing air circulation � Particle testing depending on the cleanroom zone � Microbiological monitoring on a cleanroom � Requirements on construction of floors, ceilings

and walls � Classification, Qualification, Requalification of

Cleanrooms

Upgrading, Re-construction and Renovation of Facilities

� Required as built documentation to start � What to consider in re-construction projects? � How to protect the ongoing manufacturing

operations – Protection of products – Protection of equipment, rooms and HVAC – Flow concepts and control of external personal – Access control, pest control, cleaning – Documentation of protective measures –Examples from recent projects

Qualification and Management of Technical Suppliers � Contract management: Commercial vs. Engineering

vs. GMP issues � Selection and auditing of suppliers with a risk-based

approach � How much GMP must a supplier have? � Review of suppliers and their performance � How to audit a technical supplier? � Examples of managing suppliers for equipment,

technical services, ...

Pharmaceutical Water Systems � Regulation basics � Generation: Purified Water, WFI, Pure Steam � Components: working principles and hazards

(Softener, EDI, RO,...) � Storage and Distribution concepts � Sanitisation principles, avoidance of biofilms � Automation, Instrumentation, Trending � How to handle OOS in a water system

Maintenance & Calibration � Life-cycle model of pharmaceutical equipment � How to set up and maintain a maintenance/calibra-

tion system � Definition and control: frequencies, activities, toler-

ances, acceptance criteria, etc. � Timing of activities � Documentation & labeling � Data integrity

Impact of the new GMP Thinking on Engineering � Impact of the new Annex 15 � State of validation / qualification in the US � Impact of ASTM E 2500 on European projects � Changes coming from ICH Q 8-10 � How to comply with EU and US requirements in

technical projects � Practical examples

“Great course!”Peter Dalsgaard Mønsted, Region Sjælland Sygehusapoteket, Denmark

“Very interesting course. Not too broad nor too specific. Good level of speakers / talks.”Dr Raf De Dier, Cilag AG, Switzerland

“It was a pleasure to be present in this conference.”Sergio Guerreiro, Iberfar, Industria Farmaceutica SA, Portugal

Speakers

Dr Jean-Denis Mallet ECA, former head of the French Inspection Department AFSSAPS, NNE PharmaplanJean-Denis Mallet is a pharmacist. He was previously the Head of the Pharmaceutical and Cosmetics Inspection Department at the French Health Products Regulatory

Agency (Afssaps=ANSM). He also used to work in or with the pharmaceutical industry during many years at various positions including Quality Assurance, Production Man-agement, Engineering and GMP Consulting. He has also been auditor of the International Red Cross. Now he is member of the ECA advisory board and works for NNE Pharmaplan.

Gert MoelgaardPast Chairman of ISPE, Senior Consultant, Moelgaard Consulting Gert Moelgaard has been Vice President for Innovation & Business Development in NNE Pharmaplan. He has been working in the pharmaceutical industry since 1982

and has experience from a number of major engineer-ing, automation and validation projects within pharma-ceutical manufacturing. He has made international con-tributions in international conferences on automation, process validation, PAT and manufacturing excellence and has contributed to several books and technical guidelines. Now he is working in his own consultancy business.

Markus MulthaufSenior Consultant GMP-EngineeringMarkus Multhauf studied process engi-neering (TH Karlsruhe). He worked for HOECHST and for plant construction companies like Waldner and Hager+ Elsasser. At LSMW/M+W he was design

engineer for utility systems and project manager for 9 years. Then he was head engineering at Aeropharm (SANDOZ/Novartis). Since 2013 he is a freelancing engineer for pharmaceutical technology.

Stephan ReuterOptima PharmaStephan Reuter has more than 20 years experience in the pharmaceutical indus-try. He started his career in plant engineer-ing for puremedia systems on the supplier site. He changed to the consulting busi-

ness and has been Head of Engineering at Chemgineer-ing were he was responsible for many pharma projects. He also worked for B.Braun in the position of the Global Head of Project Management. Now he is again working in the field of plant engineering and construction as the managing director at OPTIMA pharma.

Dr Ingrid WaltherPharma Consulting Walther, Former Head of the Business Unit iv Drugs, FreseniusDr Walther joined Fresenius AG in 1986. She was employed in various positions and has long years of experience in the fields of research and development, qual-

ity assurance/quality control and the management of strategic projects. In 1997 she assumed a position as head of the Business Unit Validation and GMP Compli-ance at Pharmaplan GmbH. In a subsequent position at Pharmaplan, she became responsible for consulting pro-jects and became COO. In 2007, she re-joined Fresenius, heading the business unit iv Drugs & Oncology. Since July 2009 she runs her own business as consultant.

Social Event

In the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Organisation and Contact

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

CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg, GermanyPhone +49 (0) 6221/84 44-0, Fax +49 (0) 6221/84 44 34E-mail: info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content please contact: Dr Robert Eicher (Operations Director) at +49 (0)6221 / 84 44 12, or per e-mail at eicher@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc. please contact:Ms Jessica Stürmer (Organisation Manager) at +49 (0)6221 / 84 44 60, or per e-mail at stuermer@concept-heidelberg.de.

GMP/GDP Certification Programme

This seminar is recognised within the GMP Certification Programme. By attending selected seminars, the partici-pant can acquire an additional certificate. We offer the following modules:

ECA Certified Validation Manager ECA Certified QA Manager ECA Certified API Production Manager ECA Certified Quality Control Manager ECA Certified Technical Operations Manager ECA Certified Computer Validation Manager ECA Certified Regulatory Affairs Manager ECA Certified Microbiological Laboratory Manager ECA Certified Sterile Production Manager ECA Certified Biotech Manager ECA Certified Pharmaceutical Development ManagerECA Certified GMP AuditorECA Certified GDP Compliance ManagerECA Certified Packaging ManagerECA Certified Data Integrity Manager

On the internet at www.gmp-com-pliance.org you will find a text ex-plaining which seminars are recog-nised for which certificates. Or you send an e-mail to info@gmp-compliance.org or a fax to +49-6221- 84 44 64 with the re-quest for information about the GMP Certification Programme. We will then send you our brochure on the topic.

What are The ECA Foundation and the ECA Academy?

The European Compliance Academy Foundation (ECA Foundation) is an independent professional organisation chaired by a Scientific Advisory Board with members from the pharmaceutical industry and regulatory authori-ties. The ECA Foundation’s goal is to support to the Phar-maceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guide-lines by providing information and interpretation of new or updated guidances. The ECA Academy offers profes-sional basic and advanced education (training) pro-grammes. All services offered by the ECA Academy and with regard to ECA Academy Memberships are solely managed by Concept Heidelberg (a leading European training and information services provider). The ECA Foundation is conceptual sponsor of the ECA Academy.

How Do You Become a Member of ECA?

By participating in one of the ECA Academy Conferences or Courses you will automatically become a ECA Acad-emy Individual Member for two years - free of charge. More information about ECA Academy can be obtained on the Website http://www.gmp-compliance.org

What Are the Benefits of ECA?

During the membership, you enjoy

� free access to the members’ area where you always find the latest update of the “GMP Guideline Man-ager” online version – allowing you to access a GMP tree with guidelines sorted by topics or by authority. It lets you find relevant guidelines quick and easy. And as member you can also get to this detailed tree with the GMP WebApp on your smartphone or tablet PC.

� a 200,- Euro rebate for any ECA course and confer-ence, plus the opportunity to complete the GMP Certification Programme with an internationally recognised certificate.

Use the GMP App at no costs!

The ECA Foundation has developed a GMP App which offers a comprehen-sive GMP Guideline database with more than 1,400 GMP Guidelines and ten thousands of pages. Check relevant Guidelines (full text versions) during internal audits, regulatory inspections or GMP compliance meetings – simply on your smartphone or tablet PC. In addition to this wealth of guideline information the GMP App also com-

prises features like GMP News, a comprehensive GMP Search Engine. To open the app just enter app.gmp-com-pliance.org in your browser and the WebApp opens immediately.

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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

Date

Tuesday, 19 March 2019, 09.00 to approx. 17.50 h(Registration and coffee 8.30 Uhr – 09.00 Uhr)Wednesday, 20 March 2019, 09.00 to approx. 17.45 hThursday, 21 March 2019, 08.30 to approx. 14.45 h

Venue

Radisson Blu Park Royal Palace Hotel ViennaSchlossallee 81140 Vienna, AustriaPhone +43 (1) 891 10 - 0info.parkroyalpalace.vienna@radissonblu.com

Fees (per delegate plus VAT)

ECA Members € 1,790APIC Members € 1,890Non-ECA Members € 1,990EU GMP Inspectorates € 995

The conference fee is payable in advance after receipt of invoice and includes confer-ence documentation, dinner on the first day, lunch on all three 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 when you have registered for the event. Please use this form for your room reservation to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel. Early reservation 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.

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