ABOUT THE EVENT
PHARMACEUTICAL PROCESSING SUMMIT: from Sterilization to Packaging – This conference was designed with a primary focus on knowledge exchange, catering exclusively to industry leaders and decision-makers. Experts in the fields of Sterilization, Validation, QA/QC, Fill-Finish, Lyophilization Technology, Aseptic Manufacturing, Equipment, Packaging, Regulations and many other related areas will be in attendance.
We understand that companies may have different travel policies and potential countrywide travel restrictions, so in order to prevent limitations on attendance, we will be holding this conference in a virtual format. Our virtual platform enables attendees to access the conference via a web browser or suitable IOS and Android applications. All presentations and Q&A sessions will be conducted in real-time.
This cutting-edge conference will focus on the latest developments and trends in the Pharma industry, in addition to discussing the FDA Guidelines and the EU GMP Annex 1. With the pharmacological and biotechnical markets constantly changing and evolving, our expert speakers will address the challenges that can be faced, and cover a wide range of topics, such as: Pharma 4.0, Digitalization, New Validation Cases, Flexible fill/finish, Smart Packaging, Automation and Robots and Sustainable Manufacturing.
Don’t forget to mark 26th -27th January 2022 in your calendar!
CONFERENCE LEARNING POINTS
- Updates in Regulations
- Digitalization in Lean Manufacturing
- Risk Identification and Mitigation Strategy
- Visual inspection of Packaged Products
- Continuous Improvement of Sterile Manufacturing
- Energy Efficiency
- Smart Manufacturing Technologies
- Single Use System Integrity Test
- Visual Inspection of Packaged Products
- Automation and Robots
- Innovations in Isolator design
- Best Practices for Scaling-Up Filling Operations
- PAT for Lyophilization Cycle Development
- Freeze Drying Cycles for Large Scale Manufacturing
- Modular Manufacturing Facility
– providing and combining technical and digital manufacturing expertise,
– developing and implementing innovative, scientific, customer oriented process and improvement solutions,
– providing a high standard of asset availability, reliability, efficiency and
– ensuring compliance over the entire asset and process life cycle.Leading more than 130 people in 8 large teams of highly qualified experts which.
– Develop and manage the life cycle of all packaging and device components
– Qualify and Validate processes and equipment for aseptic processing of biologic, solid and antibiotic drug products and finished goods. Deep manufacturing science expertise.
– Provide excellent expertise and services for cleaning validation and trace analytics
– Drive Reliability Engineering and Lifecycle Management for Maintenance Processes
– Provide Calibration Services and continually improve Maintenance Strategies, Spare Parts design
– Provide Ownership for critical utilities, responsible for maintaining facilities that are fit for purpose
– Design, Implement and Validate Digital Manufacturing processes, visualize complex processes in a lean way and develop automation concepts.
– Monitor and oversee Products, Processes and Media. Driving and implementing continuous process verification.
Mathew is the QMS Manager for AstraZeneca North Ryde Sydney and previous has worked for same of the biggest names in pharma including Pfizer, GSK and Roche and holds a Master’s Degree in Pharmaceutical Technology and Quality Assurance.
She is a strategic leader, carrying rich experience in designing Quality system, Complaint and Deviation investigations, Change management, Quality risk management, Batch releases, Media fills, Qualification and Validation pertaining to sterile manufacturing and microbiological controls.
Has experience in regulatory submissions for sterile products including combination product. Extensive experience of Health authority Inspection management and CAPA management.
Cares deeply for patient safety. Served as a passionate culture change champion and role model in improving the quality culture. Enjoys working with people from diverse culture. Believes in team building, training, knowledge sharing and mentoring. Works on continuous improvement and issue resolution to achieve effective quality system.
She is committed to continue to contribute her expertise for keeping product quality, safety and efficacy as priority in any organization she works.
In November 2019, Dr Thielmann moved to a new responsibility at Takeda Manufacturing & Supply as Operational Excellence Director, where he is responsible for the implementation of process improvements in the manufacturing of a wide portfolio ranging from small molecules to ATMPs with special focus on digitalization & automation.
Cleaning validation experience includes development, validation, and continued process verification (CPV) for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. Scope of work involved start-up, remediation, legacy process justification, and increasing manufacturing capability. Prepared every type of document related to cleaning validation and have executed every aspect of the cleaning validation process. Successfully defended created and legacy cleaning validation documents, programs, and concepts in numerous US and OUS regulatory audits.
Experience also includes process validation, equipment qualification (legacy justification and science/risk based), analytical methods and equipment, change management, and risk management.
Successfully managed direct reports and contractors on numerous projects (i.e., new equipment and products, site assessments, periodic reviews, legacy remediation, and campaigning).
Present yearly at numerous cleaning validation, cleanroom, and process validation conferences and webinars.
He joined Eli Lilly at the Italy manufacturing plant site in 1988. Over the 33 years with Eli Lilly, Dr. Giusti has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Production, Technical Director/Qualified Person, Six Sigma, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.
Among the several experiences with Lilly, he has worked both in United States (2.5 yrs, from 1992 to 1994) and in United Kingdom (2.5 yrs, from 1997 to 1999).
From late 2003 to late 2019 he has led the Lilly Italia Tech Serv/Validation and Procurement, contributing to Lilly Italia mission change from Sterile and Oral cephalosporin to Insulin/Biotech products, with implementation of new technologies based on isolators.
In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (especially Universities) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.
Currently he is PDA Co- Chair for the Process Validation Interest Group and he is a member of PDA Science Advisory Board (SAB)