Cleaning & Sterilisation, 25.-26th April 2023, Copenhagen, Denmark

Igor Gorsky has been a pharmaceutical industry global expert for over 40 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire. He is currently holding a position of Principal Consultant at Valsource. Igor’s over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He published numerous articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he had been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, PDA Brazil and other forums. He is also very active with PDA co-leading several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He is leading PDA Water Interest Group.  He also is a voting member of ASTM E55, Workgroup 15778 Committee Team drafting a Standard for Cleaning Validation. He serves on Board of Directors for IVT and CPCI.
Igor is an author of a book on Principals of Parenteral Solution Validation and Pharmaceutical Scale-Up. He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.

Ioanna-Maria Gerostathi works as a Qualification and Validation professional in Life Sciences.
 
Ioanna-Maria has worked in various roles in Quality Assurance, Validation and Engineering and has hands-on experience in Cleaning Validation, Equipment, Facilities and Utilities Qualification.

Ioanna-Maria has set sampling plans and trained teams in sampling activities for Cleaning Validation. Her academic background is in Chemical Engineering.

Certified in internal medicine, Dr. Andreas Flückiger was the global head of occupational health for the Roche Group for over 32 years.

In this function, he was also responsible for setting Roche’s Health Based Exposure limits and authored or reviewed and finally approved the rationales for well over 1000 such limits.

He is a member of the Society of Toxicology and honorary member of various professional associations. Official assignments in the field of toxicology have included longstanding memberships of the Scientific Committee of Ecetoc (European Centre for Ecotoxicology and Toxicology of Chemicals) and the Swiss Governmental Advisory Board on Air Quality.

Andreas now works as a part-time consultant.

Joe Cagnassola currently holds the position of Associate Director, Validation with Boehringer-Ingelheim. In this position, Joe participates in the validation of cleaning, sterilisation, equipment and processes qualifications.

He is active in performing qualifications protocols, writing master plans and remediation and optimization efforts of process related activities. During his career, Joe has held validation position of increasing responsibility with Cardinal, Mallinckrodt, Pfizer, Alcon, and BI.

Joe has professional interests in ASQ. He obtained his Certified Quality Engineer and Auditor Certifications and has been trained in Six Sigma and Lean.
His work supporting various quality initiatives has provided him a unique experience and insight into the challenges in today’s fast paced pharma environment.

Joe earned his Bachelor of Science in Biology from Arizona State University.

Walid El Azab is an Industrial Pharmacist and a Qualified Person (QP). He is a Senior Manager Technical Services for the Life Sciences Division of Steris Corporation.  He currently provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. He also leads workshops to improve inspection readiness and contamination control levels.
 
His areas of expertise include both upstream and downstream pharmaceutical operation and validation in non-sterile and sterile processes. Walid has held various positions, including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, lead auditor, and QP. Walid’s responsibilities and experience have also included project management, handling deviations and complaints, releasing raw materials, drug products, and investigational medicinal products (IMP), conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, SFDA, ANVISA, …) audits and develop strategy approach for process, cleaning, and system gap analysis.
 
Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium, and is a certified Lean Six Sigma green belt. Walid is a lecturer at the University of Liège and Brussels (Medicine faculty in Belgium).
 
He is an active member of the PDA, ISPE, ECA, and A3P associations with numerous published articles and book chapters on contamination control. He is also active with the A3P GIC working groups on sterilisation and derouging and passivation, GMP Annex 1, and Contamination Control strategy. He leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and he is also part of the ECA task force regarding the revision of the EU GMP Annex 1. Also, he lead the ECA task force on contamination control strategy. He was a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology, and of the European Biomanufacturing (1^st to 4^th). He is also an Editorial and sub-art committee member of the PDA Letter. Finally, Walid is a board member of the Belgium Qualified Person (UPIP-VAPI) association and co-founder of the Belgium QP Academy.