NÄTVERK Klas PetzénSenior ConsultantPhone070 – 974 89 52Öppna profil Olov NormellSenior ConsultantPhone070 – 974 90 33Öppna profil Peter FrankSenior ConsultantPhone073 – 567 64 86Öppna profil Mats ÅgrenMD QAT Consulting ABÖppna profil Ulf LundkvistPQA Consulting ABÖppna profil Kerstin ErikssonKK Consulting HBÖppna profil Lotta FloderusBionista ABÖppna profil Catarina MalmbergOmnec ABÖppna profil Dmytro KolisnichenkoDMKO VVS & Projektledning ABÖppna profil Andreas FasthPQA Consulting ABÖppna profil Jonas Berglund–Öppna profil Gerald PetterssonCeylonIP Patent Consulting ABÖppna profil Filip GottfridssonFinica PM ABÖppna profil Erika EgreliusEQCÖppna profil Mohammad WahabW&E OptimizeÖppna profil Mikael OhldénOhldén Consulting ABÖppna profil Andreas HermanssonKandras ABÖppna profil Manfred MaierMaier EHS Management ABÖppna profil Erik GiftingProDeCon ABÖppna profil Mats Ågren MD QAT Consulting ABSenior QA Professional More than thirty years of experience in the field of quality assurance and associated areas in the pharmaceutical and medical device industry. QAT and its partners offer a wide range of consulting services in research, development and manufacturing of pharmaceuticals and medical devices. We mainly focus on the development and audits of quality systems that comply with European regulations for pharmaceuticals and medical devices.We can also offer complete solutions for small and large validation and commissioning projects. In each area, we provide rational and efficient solutions based on our combined experience. Thanks to a well-established collaboration with partners in nearby areas of expertise, we can build complete solutions for your immediate needs or act as an intermediary to offer the best and most cost-effective service for you. Andreas Hermansson Kandras AB Manfred Maier Maier EHS Management AB MSc, Chemical Engineering at KTH Stockholm Supporting the development of programs and systems for Environment, Health and Safety in industry. Interim EHS leader, environmental permitting. Manfred has a 30+ years’ experience from leading the development in safety and environment in pharma, life science and heavy industry. Most recently he has been leading the efforts to get a new operational permit for a life science company. Manfred has previously had senior positions in health and safety and in project management in heavy pulp and paper and energy companies. Work included leading the development of safety management systems, safety culture and safety leadership across international organizations. Catarina Malmberg MSc in Chemistry from Uppsala University Has her own consultant company Omnec AB. Project Management, QA, QC, CMC, Process Development and Manufacturing 25 years of experience in the pharmaceutical industry. Supply Chain Director and Project Manager as the latest roles with very broad experience from System projects (Manufacturing Execution Systems), Data integrity, Part 11 compliance, Business processes, Change management, Tech transfer, GxP, Design control, qualification, and validation. Worked with the entire chain in pharmaceutical manufacturing of terminally sterilized products for infusion, ranging from raw materials and API:s to finished products including packaging. Worked in QC Lab, QA-release, as a product specialist (mainly process/product chemistry and packaging chemistry) and project management. Has written plans, reports, and CMC documentation. Ulf Lundkvist PresentationI have worked within Supply Management within highly regulated pharmaceutical and medical device industry for 18 years, both as a consultant and as employed. I have international experience setting up a completely new facility regarding logistics and warehousing in accordance with ISO 13485 & GDP for medical device company Q-Med´s Asian business in Hong Kong. During the time in Asia, I was responsible for the contact with different regulatory authorities in order to secure the compliance with the regulatory laws within regulated industry. Before moving to Hong Kong, I worked as Strategic Purchasing Manager at Q-Med AB. I run my own business (PQA Consulting AB) in which I am consulting in supplier management and establishing supplier agreement. In 2010 I started as Supply Sourcing Consultant at GEMS PET Systems AB. In 2011, I was employed as Strategic Sourcing Manager at GEMS PET Systems AB and worked there until August 2019.I am helping Q-Linea with long term agreement for their consumables right now. Lotta Floderus Lotta Floderus has four years of professional experience within protein research and analysis. Lotta spent most of those years in the laboratory, where she is highly effective in performing and developing analyses. She has a leading role in method development, qualification and validation. Lotta also has experience within protein engineering, lab-scale production and optimization. Kerstin Eriksson Kerstin Eriksson 67 years, Uppsala. My keyword is: “Not to do things unnecessarily but to find smart and safe solutions” She likes working with people and is stress-resistant. Have worked in both IT and QA department and used to always work efficiently but with quality assured. Almost 30 years of experience in document management, process development and streamlining of working methods, etc. I previously worked at the Medical Products Agency (1995-2001) and Q-Med AB (2001-2018), where participated in the development/implementation of electronic document management systems. Involved in process mapping at Q-Med and development of working methods, templates, training, system management, system development. Responsible for audit hub association with external inspections etc. Dmytro Kolisnichenko Project leader/technical expert HVAC, piping, process installations and utilities, cleanrooms,control systems. Dmytro has since 2006 have worked with energy, HVAC and piping (ventilation, heating/cooling/chilled water, sewage, gases, purified water/WFI, steam, vacuum, process piping, control/automation systems, etc.), mostly within projects for the pharmaceutical industry, clean rooms and laboratories. He has primarily worked with pre-studies and basic/detail design, as a technical lead or/and design team leader. Also have been involved in procurement and tender negotiations worked as installation coordinator, construction manager, and contract manager, took part and led air- and hydronic balancing, commissioning/qualification, handover inspections.Dmytro has a solid experience of creating and evaluating system design, performing technical calculations, cost estimates, 3D-design and 3D-coordination, climate/energy simulations, creating tender and construction documentation. Dmytro also has 10 years of experience as a project leader with ultimate responsibility for project economy/resources, stakeholder management, and customer satisfaction. Jonas Berglund Project manager, Construction manager, Construction work Environment Coordinator (BAS-P/BAS-U) Jonas has since 2016 worked as project manager within projects in hospitals and healthcare sector. During this time he also has had many assignments as construction manager and construction work environment coordinator (BAS-P/BAS-U). He is used to all aspects and phases of the project. He has managed building projects and projects for technical installations both in the healthcare and pharmaceutical sectors. Jonas also has 15 years of experience as a manager with responsibility for departments economy/resources and customer satisfaction both in supply chain and document management. Erika Egrelius EQC Senior Quality Assurance & Lead auditor Quality Assurance consultant & Lead auditor Erika Egrelius has over 28 years experience in quality assignments, whereof more than 20 years in leadership positions. Experience from both Medical Device companies and Pharmaceutical development and manufacturing. Since fall 2014 Erika has her own company, Egrelius Quality Consulting AB, supporting the industry with various assignments. Quality management, Quality systems, training in GxP regulations as well as ISO 13485. Implementing new regulations MDR/IVDR. Acting as lead auditor for supplier/CMO audits and also preparing and hosting audits from competent authorities and Notified Bodies. Regulatory support as a smaller part of the portfolio. Experience from small companies as well as larger, global organizations. Erik Gifting Erik has been working in the pharmaceutical industry the last 15 years. He has a Master of Science degree in Molecular biology and have experience of various roles in the pharmaceutical manufacturing chain. The last 7 years Erik has specialized his knowledge in process development, process designs engineering and he has been leading subprocesses in bigger projects. He has also been in control of installation of new systems and equipment. He is accurate, adaptable and used to work both independently and in groups. Before Erik started his own business, he was employed at Novus Scientific as a Chief engineer, Process design engineer at Galderma and laboratory engineer at PharmaControl and Pifzer. Erik has a positive attitude and commitment; he wants to inspire others to be able to deliver the best results together Andreas Fasth Clinical Development& Medical Affairs MSc in biomedicine, PhD in translational immunology Andreas Fasth has expertise in inflammation and autoimmunity, and experience of academic research as well as work in the pharma industry. He has during the last 12 years had operational and manager positions in Medical Affairs and Clinical Development, primarily in big pharma and currently in an expanding biotech company. Andreas provides his services and medical consultants via Add a Medical AB. Gerald Pettersson Master of Science in Chemistry Patent attorney, IP Project Manager, Life Science Industry, start-up companies Gerald has more than 20 years’ experience of the Intellectual Property (IP) world. Gerald is a business-oriented adviser with core strengths in building the IP portfolio and knowledge of start-up companies in the Life Science industry and patent due diligence processes in connection with the growth of said companies. Gerald has in addition to drafting and prosecuting patents, worked extensively as a proactive “internal” patent attorney, and has been involved in building the IP knowledge base in the company, teaching the researchers an IP-generating perspective, improving the commercial potential of IP produced, participating in work relating to agreements, IP budget and cost control, due diligence and investment preparations, and being a member of local and global IP boards. Gerald has also been the respondent party in a number of due diligence processes ranging from 50 KEUR to 12 MEUR. Gerald has been working with technology ranging from materials and implants to biotechnology and pharmaceuticals. Gerald has been employed at several Swedish IP law firms and at the Technology Transfer Office of Uppsala University, UU Innovation, also supporting KTH Royal Institute of Technology, The Karolinska Institute and The Swedish Agricultural University with IP advice. Mikael Ohldén Project / Project EngineerMikael has +8 years of experience in the pharmaceutical industry in various roles such as OPEX lead, project management, validation manager and project engineer which has made him accurate, adaptable and used to work both independently and in groups. Mikael has specialized in media systems, such as WFI, N2, PV, Steam in pharmaceutical manufacturing, where he has led installation projects, validation activities and efficiency projects.Previously employed at Fresenius Kabi as media engineer, project manager and OPEX lead and at Knightec as a consultant in Quality & Management before starting his own. Mikael has previously worked as a project manager at Galderma, focusing on pure media systems, validation leaders at Pfizer against pure media systems and project engineer at GE Healthcare in solvent recycling. Filip Gottfridsson Senior Project Manager Filip har erfarenhet inom pharma- och kärnkraftsindustrin som projektledare, projektsponsor, samt konstruktionsledare. Som projektledare har han lett större fastprisprojekt med helhetsåtagande som leverantör åt pharma-anläggningar i Strängnäs och Stockholm samt genomfört tekniska förstudier. Tidigare arbetade Filip i Storbritannien och Japan med Horizon Nuclear Power’s nybyggnation av kärnkraft i Wylfva samt med moderniseringen av Forsmarks kärnkraftsverk. Hans ansvarsområden har varit huvudansvarig för projekt, budgethantering, koordinering av konstruktionsgrupper, internationella leverantörer samt entreprenörer. Filip är en engagerad och transparent person med och fokuserar på tydlig kommunikation. Filip är även certifierad som projektledare enligt PMP- och PRINCE2. Mohammad Wahab “Senior Project ManagerMSc in Chemical EngineeringProject Management, Process installations, Installation lead, process development, Validation, Qualification (IQ,OQ, PQ), Risk Assessment, Change management, Time- and resource planning, Budget planning, Stakeholder management.More than 14 years of experience from the pharmaceutical industry. Mohammad has lead minor and major projects with a budget variety from 1 MSEK up to 100 MSEK. Experience from installation- and optimization projects.” Olov Normell Olov has a M.Sc. in CIM (Computer Integrated Manufacturing) from Loughborough University of Technology, United Kingdom. Olov has more than 25 years experience from the life science industry both nationally and internationally including several management positions. During these years, Olov has been involved in a series of projects that stretching over an area from single equipment related projects to complete production units. Through the years, Olov has besides management and project leadership responsibilities accumulated solid experience in the design and construction of laboratories, production facilities, cleanrooms and support systems such as HVAC, clean utilities, plant utilities, gas installations and CIP-units, etc. He has experience in requirements for buildings and infrastructure related to the above installations. Olovs technical expertise in construction, development of process and production equipment is wide and has evolved over the years in various positions and projects in the life science industry. Most projects have also included responsibility for QA, validation and regulatory activities. Olov is a results-oriented person with a focus on quality, organizational development, economic outcomes and governance. Olov has experience in steering committee and management team work. Peter Frank CMC, Process Development and Manufacturing.Peter Frank is a professional with experience in pharmaceutical/Biotech development and manufacturing. With more than 17 years of experience in both small and large companies, and in various roles as Scientist and manager, Peter has developed an expertise within project management, CMC development, and manufacturing. Klas Petzén Higher Education Diploma, Bio-Chemistry and Organic Chemistry Project Manager, Engineering and Investment Projects, Life Science Industry Klas has more than 20 years’ experience of life science industry including management positions. Klas has primarily been managing large scale engineering projects with a focus on green field projects, the adaptation of buildings and factories/plants, manufacturing, clean rooms, laboratories, warehouses, media installations, process development and ERP-systems in accordance with cGxP. A key component in all projects has been coordination of validation, QA and regulatory affairs activities. Klas has extensive experience in project management and tollgate project models. Klas is Bas-u/Bas-p licensed. Klas has been stationed in Hong Kong on behalf of a worldwide pharmaceutical company where he was responsible for planning, implementing, and maintaining the regional engineering organization and its workflows, procedures, policies, and strategies in 8 pharmaceutical plants in Region East Asia. Klas was responsible for the regional due-diligence team and was an acting green field project sponsor in the region.