Program HighlightsAn additional highlight is the joint dinner at the end of the first training course day, where participants and trainers can get to know each other better and expand their network. Don't miss this unique opportunity and reserve the evening for this get-together.
This interactive training course takes place at the Skan Academy in the newly built Skan Headquarters in Basel.
On the first day, the focus is on glove handling. Theoretical units alternate with hands-on units, so that the participants can experience what they have heard live. On the second day, participants will get an overview of all aspects of the isolator. Here, too, both theory and hands-on units are offered.
During the training course there is enough time and space for exchange of experiences and discussions. For this reason, the training course is designed for a limited number of participants only.
Upon completion of the course, participants have understood:
- the different components of an isolator
- the interactions between the different components
The participants have learned:
- the relevant GMP regulations and other guidelines
- the do's and don'ts in daily operations
- the basic principles of maintenance, calibration, and validation
The participants can perform:
- glove testing
- handling of settle plates
- transfer of items in and out of isolator
Standard Member Price€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. email@example.com
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Wednesday, 06 March 2024
Welcome & Introduction of Trainers and Participants
Isolator Basics (Theory)
- Application of isolators
- Technical basics
- Annex 1
- Containment/ Cleaning
- Process components
Regulatory View on Annex 1
Relevant Guidelines and Regulations for Gloves
- PDA Paper
Gloves on the Isolator (Theory)
- Requirements for gloves
- Tightness (pressure, liquid)
- Insensitivity to media
- Handling by operator
- Positioning in the isolator through mock-up studies
- How do different gloves and design look like
Practical Training Divided in Group 1 and Group 2
Get to Know the Isolator (Hall)
- Isolator in operation
Gloves, Filters and Smoke Studies in Practice (Hall)
- How does a glove test work?
- HEPA filter, safe filter change, and test
- Airflow visualization and studies
Gloves on the Isolator(Practice)
- Explanation of technical specification of the isolator
- Material and design of gloves
- Positioning of gloves in the isolator
- Mock-up study
- Installation and removal of the gloves
- Working with/in the gloves on practical examples
- "easy" example
- "difficult" example"
Q&A from Day 1
End of Training Course Day 1 & Networking Event
Thursday, 07 March 2024
Recap Day 1
Microbiological Monitoring on Gloves (Theory)
- Swab test - Microbiological testing
- Visual inspection
Requirements for Environmental Monitoring
- What are the GMP requirements
- Find the right position in the isolator system
Walking through the SKAN Assembly Hall showing examples on large filling lines, small scale filling lines & material transfer systems
- H2O2 as decontaminating agent
- Interaction with water
- Cycle development
Decontamination (Assembly Hall)
- Preparation for decontamination
- Start cycle
Cleaning SKAN CleanIP (Assembly Hall)
- What is important to prepare cleaning
- What is the right method to perform cleaning and how to quantify clean
Q&A from Day 2
End of Training Course
SKAN AGRead Bio
Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.
SKAN SwitzerlandRead Bio
Guido Herzberg is a specialist for calibration and metrological qualification, he joined SKAN in 2000 as the first qualification engineer for aseptic or toxic isolator and shaped essentially the test procedures and equipment. In 2012 he founded the SKAN Academy to manage our growth and lead all new qualification engineers to sustainable quality. Guido Herzberg’s profession is the precision mechanic in the swiss watch industry, since 1987. For 10 years he worked as a specialist in development, manufacturing and installation of weather stations and meteorological instruments, e.g. part of the swiss federation project IMIS, a monitoring over the swiss alps for avalanche forecast.
Andrew D. Hopkins
Director, Operation Quality QA Audit and Compliance, AbbVie Inc.Read Bio
Andrew D. Hopkins
AbbVie Inc.Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included: • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of areas including, sterile products, biological products, blood components and plasma. • Chairperson of the Inspectorates CMT (working with marginally compliant companiese) • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites) • Inspector training and mentoring • Invovled in writing of regulatory guidance documents including: o MHRAs Data Integrity guidance o EMA guidance on water systems o Chair for the working group for the revision of Annex 1 • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20. Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.
Sales Engineer, SKAN AGRead Bio
Mathilde has studied Process Engineering. After an initial work experience in the microelectronics industry she joined SKAN AG in 2020 as a Process Validation Engineer in the Process Validation Microbiology department. She performed cycle developments and microbiological qualifications of SKAN isolators all over the world as well as E-Beam Sterilization process validation. Today she supports the Sales Team as Sales Engineer.
Alex J. Kappani
Product Management, SKAN AGRead Bio
Alex J. Kappani
SKAN AGHaving worked for several years as Product Manager for glove intervention systems at SKAN, a high amount of experience on this subject is obtained by working with numerous global Pharmaceutical companies.
Strategic Product Manager, SKAN AGRead Bio
Harald Kiesel, Dipl.-Ing, MBA is Strategic Product Manager at SKAN and responsible for the portfolio of sterile test isolators. In this position, he is mainly working for shaping the offering of SKAN isolators to meet market needs. He was able to gather experience in various roles within marketing and product management in the chemical and pharmaceutical industry.
SKAN GermanyRead Bio
Andreas Kindscher is Product Line Specialist at SKAN and works in the area of Glove Management. Since his successful master's degree in mechatronics, he has worked in various areas, but mainly in his current area - Glove Management. In this area he focuses on glove testing, glove materials and the correct use of gloves and forms the bridge between development, product and users.
Sales Engineer, SKAN AGRead Bio
In 2007 Theresa Ladwig joined SKAN AG as a Project Engineer in the department Cycle Development and performed cycle development and microbiological qualifications all over the world. From 2013 to 2018 she was Head of Process Validation Microbiology. Today she supports the European Sales Team at the SKAN headquarters.
Research Manager, SKAN AGRead Bio
Max Mittelviefhaus is a microbiologist (PhD) with a strong interest in the interface between biology and technology. In 2020, he joined SKAN AG as Research Manager in the Research and Strategic Business Development Department, where he is responsible for customer studies that SKAN offers through their SKANalytix services. In this role he is in frequent exchange with SKAN’s global clients, identifying their needs and concerns related to aseptic processing or decontamination technologies and translating these into appropriate scientific studies. SKANalytix thereby supports their clients with the necessary analytical data, to ensure quality and safety of aseptic operations in the pharmaceutical industry.
Founder & CEO, TM Pharma Group LtdRead Bio
TM Pharma Group Ltd
In her capacity as an Expert GMDP Inspector, Tracy played a pivotal role as the primary MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain. Her expertise extended to providing guidance on the regulation of QP certification and overseeing the deployment of vaccines under Regulation 174. Tracy also contributed significantly to the pharmaceutical landscape by supporting the drafting of the GMP Annex 1 update, actively sharing insights on this matter at global events such as PIC/S. Among her notable achievements, Tracy served as the MHRA Data Integrity GXP lead and assumed the role of MHRA FMD GMP lead. Her involvement extended to being a key member of drafting groups for EU GMP Annex 16, Annex 21, Annex 1, Chapter 4, and Annex 11. Tracy represented MHRA on PIC/S subcommittees and took on leadership responsibilities by chairing working groups. Before joining the MHRA Inspectorate, Tracy amassed 22 years of experience in the pharmaceutical and Bio-Pharmaceutical industry. Her diverse roles encompassed QA, QP, and management positions in both commercial and R&D environments, covering a range of sterile and non-sterile product dosage forms. Tracy's responsibilities included conducting audits and overseeing Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. With a decade of experience as a GMP Inspector and an additional three years as an Expert GMDP Inspector, Tracy has demonstrated a commitment to ensuring regulatory compliance and fostering collaboration with European and international regulatory authorities. Her multifaceted contributions extend to shaping and refining industry standards, making her a respected figure in the pharmaceutical regulatory landscape.
Innovation Manager, SKAN AGRead Bio
H2O2 decontamination technology expert and visionary, Martin is passionate about novel technologies throughout the industry and is a regular conference speaker. He serves as an Innovation Manager at SKAN’s Research to Business department, where he guides the aseptic development program. He seeks cutting edge science and works on development of novel ideas and their transformation towards industrial application.
Following his BSc from University of Chemical Technology in Prague, Martin earned his MSc in Therapeutic Technologies from University of Applied Sciences FHNW in Switzerland, where he graduated with best-in-class honors.
Sales Manager, SKAN SwitzerlandRead Bio
Ruben Rizzo began his pharmaceutical career with an apprenticeship in chemical and pharmaceutical technology at Novartis, gaining a solid foundation in industry processes, particularly through his involvement in technical R&D.
Advancing his education, Ruben studied business and process management in Basel. Since 2014, Ruben has worked as an International Sales Manager, managing project sales in Switzerland and Southern Europe. His role at SKAN, marked by involvement in numerous successful projects for pharmaceutical isolators of various applications, has honed his deep technical insights and strategic business skills. This experience has been instrumental in driving significant market expansion and in cultivating robust client relationships across these territories.
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PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Holiday Inn Express
179 Allschwil / Basel
The hotel is located five minutes walk from the training course venue.