Back

Pharma

Cleaning Validation & HPAPI Manufacturing + Pharma 4.0 Summit

  • 11th – 13th October 2022
  • Germany flag Germany Munich

This October we will bring together a dense variety of topics that will shed a light on the current situation in the world of cleaning validation and highly potent APIs manufacturing along with pharmaceutical automation (Pharma 4.0).  

The three-day summit will gather many experts from the fields that go hand-in-hand with each other, plus the automation and digitalisation of the pharma industry. We will reach all the aspects that are needed to stay up-to-date, informed, and prepared for challenges in the coming year and beyond. 

If you want to improve your knowledge, industry quality and expand your network, then the Cleaning Validation & HPAPI Manufacturing + Pharma 4.0 Summit, a great opportunity for communication with the pharmaceutical community. 

Read more

About the Cleaning Validation & HPAPI Manufacturing + Pharma 4.0 Summit 

Day 1, October 11, 2022 – 5th Cleaning Validation 

Day 2, October 12, 2022 – 8th HPAPI Manufacturing 

Day 3, October 13, 2022 – 3rd Pharma 4.0 

Who Should Attend 

Executives, Directors, Heads, Leaders, Managers, Specialists, Engineers Professionals in Pharmaceuticals, Principal Scientists, Principal Toxicologists, QC Laboratories, Manufacturers of Drug Substances (APIs), Contract Laboratories, Oral Solid Dosage Form, Clinical Research Org., Contract Research Org., Contract Manufacturing Org., Biopharma Companies, Biotechnology Prod., and Fellows specialising in:  

  • Cleaning Validation  
  • Aseptic Processing  
  • Chemistry  
  • External Supply  
  • Medika Devices 
  • Robotics & Control 
  • Continuous Processing 
  • Compliance 
  • Manufacturing Science & Technology  
  • Regulatory Affairs  
  • Business Development  
  • Commercialization 
  • Quality Assurance/Control 
  • Packaging 
  • Licensing 
  • Formulation Development  
  • Emerging Technologies 
  • Industrial Hygiene  
  • Health, Safety & Environment (HSE) 
  • Digital Strategy & Transformation   
  • Occupational Toxicology  
  • Corporate Toxicology   
  • Research & Development  
  • Process Development 
  • Data Integrity 
  • Diagnostics 
  • Track & Trace 
  • Strategic Development   
  • Risk Management  
  • Pharmaceuticals  
  • Biotechnology  
  • Documentation & Analysis  
  • Plant Management 
  • Operations  
  • New Products 
  • Product Quality  
  • Drug Safety Evaluation   
  • Process Monitoring & Control  
  • Analytical Development Laboratories  
  • Internal & External Audit  
  • Mechanical Engineering  
  • Training Departments  
  • Engineering  
  • Sterilization 
  • Vaccines 
  • Validation  
  • Production 
  • EHS  
  • QA/QC  
  • CMC  
  • CMO  
  • Technology Transfer  
  • Other 

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Cleaning Validation Lifecycle and Analytics   
  • Technical and Organisational Aspects on Equipment 
  • Managing Cleaning Validation Quality System   
  • Digitalisation and Automation of Cleaning Validation 
  • Cleaning Validation Regulatory Compliance  
  • GMP compliance and regulatory landscape 
  • Applications to achieving safety and productivity of HPAPI manufacturing 
  • Challenges with potent APIs production and exposure limits industrial hygiene and risk management for APIs plants 
  • Process development and hazard assessment in chemical/biotech APIs plants 
  • Validation on cleaning procedure to avoid cross-contamination 
  • Strategies for effective control of outsourcing partnerships (CMO) 
  • Process equipment special design for HPAPI containment system integration 
  • Smart Manufacturing, Digitalisation, and Transformation of Conventional Plants  
  • Integration and traceability of information systems to facilitate data control 
  • Effective Implementation Pharma 4.0 and Uphold   
  • Manufacturing 4.0: optimisation of quality and supply 
  • Real-time monitoring for immediate response and assessment to ongoing events 
  • Data Analytics in the Pharmaceutical Industry  

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, 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. He founded the expert Con­tainment Group of the ISPE DACH eight years ago. 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.

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Walid El Azab is an industrial pharmacist, a qualified person, and a lean six sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. Finally, he leads audits at manufacturer sites and workshops to improve processes and inspection readiness levels. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions) and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is the secretary of the Belgium Qualified Person Association.

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

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.  

To be

Announced 

To be

Announced 

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

To be

Announced 

To be

Announced 

BROCHURE  

Request the Cleaning Validation & HPAPI Manufacturing + Pharma 4.0 Summit brochure and find out the latest topics and ideas that will be shared.   

Request

Please fill in your e-mail address below and we will process your request in a moment.