4 Day Cleaning and Cleaning Validation 20 Mar 18

1 Compliance & Validation ServicesPresents a 4-DayTraining Course on: Cleaning & Cleaning ValidationPractical Day,20 March 2018, Alfa Laval Test Facility, Ish j, Copenhagen(Transport provided to and from the Radisson Blu Royal Hotel, Copenhagen)21, 22 & 23 March 2018, Radisson Blu Royal Hotel, CopenhagenPractical Demonstrations (20 March 2018): Spray device technology and fluid dynamics Riboflavin coverage demonstration and demonstrating the effectiveness of different types of spray devices for removing a range of residues Swabbing and the use of TOC to determine residue levelsThe Cleaning Process (21, 22 & 23 March 2018): Types of Cleaning action involved in Cleaning processes Cleaning process chemistry, processes optimisation and the use/evaluation of Cleaning agents Design of equipment for ease of Cleaning (includes hygienic engineering principles): Clean-in-place (CIP) systems Clean-out-of-place (COP) systems Cleaning of biopharmaceutical plant real life case studies Resolving Cleaning issues that may arise in practiceCleaning Validation (21, 22 & 23 March 2018).

2 Key international regulations and guidance and their impact on what we do Establishing limits for maximum allowable levels of carryover (large molecule [ biopharmaceutical residues], small molecule compounds and Cleaning agents) Incorporating the Annex 15 & EMA Guidance on Health Based Exposure Limits categorising compounds as Highly Hazardous and Non-Highly Hazardous + applying full toxicological assessments or using dosage based limits Using a matrix approach to multi-product non-dedicated plant Cleaning Validation Saving time and effort by focusing on the worst case materials/residues Review and comparison of methods used for sampling and detecting/quantifying residues Application, method development and qualification/ Validation of Total Organic Carbon (TOC) methods (sampling and analysis) Spray device coverage verification demonstrating all internal surfaces can be wetted Using Risk assessments to determine the level of testing required (product quality/patient safety) Key Validation considerations and Validation documentation requirements Alternative technology avoiding the need for Cleaning Validation , disposablesPhotograph courtesy of Alfa Laval<< Click here for more information >>1 Note: This course can be booked as a 3-day option (without the Practical Day)<< Click here to down-load a 3-Day course brochure >>The Practical Day will be held at Alfa Laval s Full Scale Test Facility.

3 Complementary transport will be arranged for delegates from the Radisson Blu Royal Hotel at 09:30. Those wishing to make their own way to the facility should target a 09:50 am arrival time. Tea/Coffee and lunch will be provided. Complementary transport will be provided from the facility back to the Radisson Blu Royal Hotel, Address: Alfa Laval Tank Equipment A/S, Box 1149, Baldersh j 28, 2635 Ish j, Denmark (link for map provided See opposite)Practical Demonstration of Tank Cleaning Technology - Tuesday 20 March 2018 - 09:30 - 09:50 (Bus); 10:00 to 16:30 (Facility); 16:30 17:00 (Bus)Venue This day will help provide a platform for learning for the hotel based presentations to follow. Delegates will get the opportunity to see tank Cleaning technology actually working in real time, using full scale vessels pipework/valves, instrumentation and spray devices. They will see and hear how different spray devices perform under typical conditions in real life.

4 The demonstrations will also show how static, rotary spray and rotary jet head devices perform, when faced with a range of residues of different physical and chemical properties. A practical demonstration of Riboflavin coverage verification will be included together with short presentations on Cleaning technology and fluid dynamics in relation to Cleaning . Swabbing demonstrations and TOC determinations (using a TOC instrument) will also form part of the day. The additional day will be very beneficial to those delegates who are interested in expanding their understanding of spray device technology and in optimising their Cleaning processes. There will be many opportunities to ask the experts questions during the day. Complementary transport will be provided (see below for more details).Day 1 Programme (10:00 to 16:30)2 Click on image to view location on Google MapsTimeActivity09:30 Depart (bus) from Radisson Blu Royal Hotel (Assemble by 9:20)09:45 to 10:00 Arrival at facility and general welcome/introduction10:00 to 11:20 Vessel Cleaning technology, hygienic design and fluid dynamics in relation to Cleaning (presentations)11:20 to 11:35 Tea/coffee break11:35 to 12:30 Riboflavin spraying and removal demonstrationYogurt removal demonstration, using different types of spray heads12:30 to 13:15 Lunch13:15 to 15:00 Tank/Vessel coverage demonstrations using a variety of different spray heads/devicesDemonstration of the relative power of sprays from a variety and sizes of devices, when Cleaning difficult to remove :00 to 15:15 Tea/coffee break15:15 to 16:20 TOC determinations and presentation with Jamie Thompson16:20 to 16.

5 30 Final questions and answers and closure of Day 116:30 Depart (bus) from Alfa Laval to the Radisson Blu Royal Hotel, CPH ETA 17:00 Full Scale Test Facility Alfa Laval, Ish j Hotel Based Course Summary: Cleaning & Cleaning Validation : 21, 22 & 23 March 2018, Radisson Blu Royal Hotel, CopenhagenPresentersThis course provides essential knowledge/learning for anyone involved in any aspect of biopharmaceutical and pharmaceutical equipment Cleaning and Validation . Target disciplines includeengineering (including equipment designers), production (management, supervisors and processoperators), technical support, Validation , quality assurance and quality leaving this course delegates will: have a better understanding of the applicable regulatory rules and guidance and other pertinent international standards/guides; have a clear understandingof the fundamental principles and current industry practice related to Cleaning and Cleaning Validation ; have a sound understanding of the equipment design principles for ease of Cleaning ; beable to calculate limits and develop a supporting rationale for maximum allowable carryover of a wide range of residues; have many practical real-life examples of how Cleaning and cleaningvalidation is actually carried out in industry; be able to apply and share their new knowledge.

6 Improve their individual effectiveness; and look backon an enjoyable (21, 22 & 23 March 2018) See Page 2 for Practical Day VenueWho Should AttendThis course provides delegates with an in-depth appreciation of key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable easy , effective Cleaning . It also provides a detailed understanding of the approach to validating Cleaning processes. This includes the fundamental understanding of material carryover (contamination) mechanisms and how this is pivotal to setting appropriate limits for acceptable levels of carryover (maximum allowable carryover [MACO] limits) from one product to another. The course also covers areas such as applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO (large/small molecule compounds & Cleaning agents); methods for sampling/detecting/quantifying residues; inclusion of clean/dirty hold times in the Validation study; the use of a matrix approach to multi-product non-dedicated equipment; Cleaning process monitoring/review and maintaining the validated state.

7 To help consolidate your learning, presentations will be supplemented by case studies and workshops. Day-time meals and refreshments together with a course dinner, held on the evening of Day 1 of the Hotel based course (Wednesday), are included in the overall package. This course starts with a Practical Day, which will be held at Alfa Laval s Fluid Test Centre. During this day, delegates will be presented with information on dynamics of fluid flow , hygienic engineering and spray device technology. There will be demonstration of how coverage can be verified (using Riboflavin). Further demonstrations will show how different types of spray devices perform with different types of residues with differing degrees of difficulty to clean. Swabbing and TOC analysis will also be covered. The Practical Day will help strengthen learning over the following three days of hotel based Blu Royal Hotel, Copenhagen, Hammerichsgade 1, Copenhagen V, DK-1611, Denmark:Situated across from the city's main train station, this Copenhagen hotel s city centre address makes it easy for guests to explore the area.

8 Stroll tothe fashionable stores of Str get shoppingdistrict and the fun of magical Tivoli :+45 3342 6000 Fax: +45 3342 6100 Email: reservations:Tel: +45 3815 6500; Fax: +45 3815 6501; Europe toll free: 00800 3333 3333 Email: are kindly requested to arrange their own fees are 1, (GBP)per is NOT included in the course fees3 Mike James, Training Director, Compliance & Validation Services Limited.:Mike has 25 years experience in the pharmaceutical industry, working in a varietyof compliance and Validation roles. His experience includes preparation anddelivery of national/client-based Validation training courses, hands-on validationwork, Validation project management and regulatory compliance , Mike spent four years as the Site Validation Manager forGlaxoSmithKline (GSK) at Speke, where he was responsible for all site validationactivities, including the development and maintenance of the Site ValidationProgramme.

9 Before moving to the pharmaceutical industry he spent 15 years asan industry Welbourn, Consultancy Director, Compliance & Validation ServicesLimited:A Validation professional with over 30 years experience, John hasbeen responsible for the management and execution of Validation projects formany major pharmaceutical has broad experience in thequalification of equipment, utilities and computerised systems, and thermalmapping to support storage conditions. He has presented at conferences in theUK, Europe and the US and has authored several articles on various aspects has contributed to The University of Manchester s,Pharmaceutical Engineering Advanced Training (PEAT) Course and DublinInstitute of Technology s (DIT) MSc. course in Pharmaceutical Cleaning Validation Industry Speaker:Our IndustryExpert Speaker has many years experience of working in the BiopharmaceuticalManufacturing Industry and has a wealth of knowledge/expertise in the areas ofprocess Validation and Cleaning Thompson, Independent Consultant & Validation Specialist:Jamie iscurrently in a laboratory equipment Validation role, where he is validating anextensive range of laboratory analytical/test equipment.

10 Up to recently he was aSpecialist at Sievers TOC analysers (part of GE) and the use of TOC analysis forUltra-Pure Water Systems and Cleaning Validation . Previous to this, Jamie spentover 10 years working in an analytical chemistry role for major pharmaceuticalmanufacturers (GSK and Pfizer).These roles involved raw material/finishedproduct testing relating to pharmaceutical and bio-pharmaceutical manufacturingand specifically, chemistry testing of high purity water systems and cleaningvalidation samples. Other areas of Jamie s experience include working with site-wide systems such as SAP, Trackwise, laboratory information systems (LIMS),failure investigations and change control. Jamie has a Masters in on images to visit the Hotel s websiteCleaning & Cleaning Validation - Radisson Blu Royal Hotel, Copenhagen Hotel Based Course Programme:Registration (08:45 to 09:00) Delegates arrive at the meeting room and sign the attendance register.