Richard Denk studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment, and eight years ago he founded the expert containment group of the ISPE DACH. The containment group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Igor Gorsky has been a pharmaceutical, biopharmaceutical, and medical device industry professional for over 39 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He worked in production, quality assurance, technical services, and validation, including as an associate director of global pharmaceutical technology, at Shire, where he oversaw global validation efforts, including analytical methodology, equipment and facilities qualification, process, packaging, shipping, computer and cleaning validation, and environmental monitoring programs. He is currently a senior consultant at ValSource, LLC. Over the years, his accomplishments include validation of all the aspects of pharmaceutical, biotechnology, and medical device production and quality management, technical support of multi-billion-dollar drug product lines, and introduction of new products onto the market.

He developed analytical technology policies, procedures, and master plans for numerous biopharmaceutical firms based on latest global regulation. He also developed analytical technology qualification programs for many pharmaceutical and biopharmaceutical firms. He has published numerous articles and white papers in pharmaceutical professional magazines. He is an author of two books on pharmaceutical scale-up and process validation. In addition, he has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, and other forums. He is also very active with PDA and ASTM participating in several task force groups authoring PDA technical reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), and 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He leads the PDA water interest group and is also a member of ASTM E55, G122).and participated in the ASTM E3106-18 Standard Guide for Science and Risk-based Approach to Cleaning Validation, and the ASTM E3219 and E3263. He holds a BS degree in mechanical/electrical engineering technology from Rochester Institute of Technology.

Morcos Loka is a training manager and GMP advisor at Minapharm. Over 23 years, Morcos has played different production and quality roles in the pharmaceutical and biopharmaceutical industries. His experience includes the manufacture of sterile and non-sterile products, handling of regulatory and customer audits, conducting internal and supplier audits, GMP gap analysis, GMP training, GMP consultation, establishing quality management systems, management review, quality metrics, establishing quality risk management system, QRM studies including manufacturing of HPAPIs in shared facilities, and design of pharmaceutical and biopharmaceutical manufacturing facilities.
Morcos has an MBA, a BSc with honours in pharmaceutical sciences, two postgraduate diplomas in total quality management (TQM) and train of trainer (ToT), and four professional certificates: ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), and ISPE Certified Pharmaceutical Industry Professional (CPIP).

Morcos is an ASQ, ISPE, and PDA member. He participated in different ISPE and PDA publications and as a speaker in different IVT, ECA, PDA, and ISPE pharmaceutical industry conferences.

Andreas Flückiger, MD, holds Swiss governmental certifications in general internal and occupational medicine. Before his retirement from the company in 2018, he was chief occupational health officer for the Roche Group for over 32 years. In this corporate function, he managed Roche’s occupational health and its hazard assessment programs. This activity included standard-setting, auditing, and teaching activities in the broader field of HSE, particularly in occupational health. Between 1986 and 2018, he and his team set health-based exposure limits for over 2,000 molecules. He has participated in numerous training courses on the GMP context in which these limits are used, in particular quality risk management in multi-product facilities. Andreas is a member or honorary member in several professional organisations. He now continues to work as a consultant mainly in the areas of occupational toxicology, exposure control by containment design, and general HSE matters.

Thomas Altmann has 22 years’ experience in cleaning chemistry, cleaning process, cleaning validation, and regulatory compliance. As technical consultant and validation manager, he provides technical consultation on cleaning and sanitisation process optimisation for pharmaceutical, API, biotechnology, and personal care manufacturers in Europe, Middle East, Asia Pacific, North America, and Africa. In his role, Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment.

Dr. Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development department of the pharmaceutical business unit of Bayer. 

He is responsible for the release of chemical APIs for clinical trials, the GMP-quality system, and the QA-oversight of the pilot plants and analytical development laboratories.

Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany.

He has about 20 years of industrial experience at Bayer AG in different QC/QA-functions and two years' post-doc experience at Novartis in Switzerland.

He is and was involved in many technical (transfer) projects as well as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept for the chemical development department.

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors.  

Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.  

Prior to joining Valgenesis, Sunil has had variety of Validation roles as consultant and corporate employee with increased responsibilities within Pharmaceutical and Biologics industry including Catalent, Eisai, Pfizer, Teva and Novartis.  

Steve Marnach has a master’s degree in business administration and has with DuPont since 1995. After having held various positions within the company, he is currently the EMEA training manager and critical environments marketing specialist for DuPont personal protection, the chemical protective and cleanroom garments business that Steve has been working for since 2003. In his current role, Steve provides training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade A/B and C/D cleanroom operations as well as gives technical support to health and safety specialists.

Martin Kohan is a managing toxicologist for SafeBridge Regulatory and Life Sciences Group. He has a BSc and MSc in biochemistry from La Plata National University, Argentina, as well as an MSc in pharmacology and PhD in medical sciences from the Hebrew University of Jerusalem, Israel. Martin has over 11 years of industry experience in the field of toxicology conducting and managing over 1,000 hazard and risk assessments, including calculation of exposure limits and/or determination of exposure control bands for drug substances and isolated intermediates and quality deviations (impurities and extractables and leachables) for Teva (2010-18) and AstraZeneca (2018-22). He's a Diplomate of the American Board of Toxicology (DABT), a European Registered Toxicologist (ERT), and a member of the UK Register of Toxicologists and the British Toxicology Society.

Thomas Weingartner is the managing director of Lugaia Deutschland GmbH. Previously he held managerial positions in powder handling companies and has been active in the field of containment for more than 20 years. Thomas develops customer-specific containment solutions on the basis of high-quality film materials. His experience includes pharmaceutical industrial hygiene and safety for other industries such as life science and fine chemistry. Thomas has a wealth of experience in providing and installing containment solutions to minimize the risk of contamination.

The core competence of Lugaia lies in the market-ready products based on film, which customers use as single-use solutions in hygiene process technology. The film systems manufactured in clean rooms are used once and then disposed of. This eliminates the need for expensive and time-consuming cleaning processes for the systems and the costly qualification procedures that go with them.

Ravi Moorthy has a master’s degree in biomedical engineering from Columbia University and worked in the US with Pall Corporation and 3M Healthcare prior to starting Quascenta. Ravi has 20 years of hands-on experience in cleaning chemistry and cleaning validation. He has been instrumental in implementing detergent-based cleaning and scientifically justifiable efficient cleaning validation programs at several companies worldwide including Novartis, Pfizer, AbbVie, and Teva. He was a pioneer in digitalising MACO limit calculations with the residue application launched over 20 years ago, and Quascenta’s eResidue being one of the first pharmaceutical applications to move to the cloud in 2014. 

Lukáš Dvořák is a pharmaceutical consultant with more than 15 years of experience in the pharmaceutical industry over Europe and Asia territories. He mainly focusses on the establishment and maintenance of the pharmaceutical quality systems, both production and quality practice. He has auditor skills and practise and is a professional adjudicator in the Czech Accreditation Institute.