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cGMP Annex 1 Workshop

  • 9th – 10th May 2023
  • Spain flag Spain Barcelona

The final version of the EMA revised Annex 1 was published on August 25, 2022, seven years after the revision process started. The revised annex becomes effective on August 25, 2023, except for section 8.123, which contains the requirement for lyophilisers that are manually loaded or unloaded with no barrier technology separation to be sterilised before each load, which becomes effective one year later, on August 25, 2024.

The final draft has 59 pages, which is dramatically longer than the 16-page 2008 version. This revision is a complete rewrite of the annex and was a joint EU, PIC/S, and WHO project, with US FDA personnel actively involved. The new Annex 1 revision must be implemented within one year of its issuance, by August 25, 2023.

The cGMP Annex 1 Workshop will feature industry experts who will provide practical solutions for implementation of the new guidelines at your organisation. These experts were intensely working on commenting and developing solutions for Annex 1 changes throughout the entire seven-year process since the publishing of the first draft of this virtually new guidance. They will provide a unique expertise on the gap issues you may have in your facility regarding Annex 1 implementation and can recommend a viable path forward. Attending this workshop will help your organisation avoid regulatory scrutiny and numerous observations.

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About the cGMP Annex 1 Workshop

This workshop training program is designed by field experts with a focus on necessary topics not only for product manufacturing, but for whole complaining sectors, including engineering, equipment manufacturers, and equipment suppliers.

After the final revision to Annex 1, published in August 2022, sterile medicinal products manufacturers are required to comply by August 25, 2023, with the exception of engineering solutions for lyophilisers.

The workshop will primarily concentrate on these key areas of Annex 1:

  • Pharmaceutical Quality Systems
  • Equipment, Technology, and Utilities
  • Production Technologies

Some of the topics discussed will include:

  • Evolution of Annex 1 and the reason for its introduction as it is important to understand origins of the proposed changes in order to proper implement them
  • An in-depth discussion on the key organising documentation required by Annex 1 and how it might impact drug suppliers
  • An extensive use of risk management in Annex 1 changes implementation and readiness of firms to use risk management, per Annex 1 requirements and in a light of ICH Q9 new revision
  • What should be taken into consideration when renovating, expanding, or building new facilities with Annex 1 in mind?
  • The media-fill design expectations in revised Annex 1 and method to consider for interventions

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: 

  • Sterilisation 
  •  Cleaning Validation 
  • Aseptic Processing  
  • Chemistry  
  • External Supply  
  • Continuous Processing 
  • Compliance 
  • Manufacturing Science & Technology  
  • Regulatory Affairs  
  • Business Development  
  • Commercialisation 
  • Quality Assurance/Control 
  • Packaging 
  • Licensing 
  • Formulation Development  
  • Industrial Hygiene  
  • Health, Safety & Environment (HSE) 
  • Occupational Toxicology  
  • Corporate Toxicology   
  • Research & Development  
  • Process Development 
  • Strategic Development   
  • Risk Management  
  • Pharmaceuticals  
  • Biotechnology  
  • Plant Management 
  • Operations  
  • New Products 
  • Product Quality  
  • Drug Safety Evaluation    
  • Process Monitoring & Control  
  • Analytical Development Laboratories  
  • Internal & External Audit  
  • Training Departments  
  • Engineering  
  • Vaccines 
  • Validation  
  • Production 
  • EHS   
  • QA/QC  
  • CMC  
  • CMO/CDMO  
  • 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

  • Principles and Pharmaceutical Quality Systems
    • Using QRM to Enable the Contamination Control Strategy
    • Contamination Control Strategy Development
    • Considerations of Annex 1 for ATMPs and Low Bioburden Products
    • RABS Gloves Testing and Visual Inspection
    • RABS vs. Isolator
  • Equipment, Technology, and Utilities
    • Decontamination and Sterilisation of Direct and Indirect
    • Product Contact Surfaces
    • Water Systems and Other Critical Utilities
    • How Equipment Is Transferred into an Isolator Class A
  • Production Technologies
    • Aseptic Processing
    • Filtration and Pre-Use, Post-Sterilisation Integrity Testing
    • Container Closure Integrity Testing and Finishing
    • Production and Specific Technologies (Blow-Fill-Seal, Lyophilisation, Single-Use System, and Terminal Sterilisation)

Igor Gorsky, US

Principal Process Validation Consultant

ValSource Inc.

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, EG

Training Manager & GMP Advisor

Minapharm

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.

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.

Yossi Shapira, IL

Consultant and Owner

Containment Lyophilization Laboratories (CLL)

Yossi Shapira is a consultant expert in lyophilization and HPAPI processes containment and exposure solutions, as well as chemical laboratories design. He is the founder and owner of Containment Lyophilization Laboratories.

Yossi served 40 years at TEVA Pharm. Ind., where he gained substantial experience in parenterals production, freeze drying processes, HPAPI handling, and most recently he spent six years in the global engineering department on special projects and technologies.

Overall, Yossi supported investigation development and optimization scaling up of lyophilization methods and safety managing for binary organic solvents solutions, drug substances, and drug products. The lyophilization process requires laboratory studies on critical parameters. Accordingly, Yossi designed and adapted the lyophilization process, trained and taught OJT, and scaled up the tested freeze-drying processes. It was also his responsibility to review new freeze-drying processes design, and he submitted processes to regulatory bodies prior to product file submitting.

Yossi is a member of the International Society for Lyophilization Freeze Drying ISL-FD and has been a guest speaker, lecturer, trainer and chairperson at several international conferences over the years.

Presenter

Coming soon

Igor Gorsky, US

Principal Process Validation Consultant

ValSource Inc.

Morcos Loka, EG

Training Manager & GMP Advisor

Minapharm

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Yossi Shapira, IL

Consultant and Owner

Containment Lyophilization Laboratories (CLL)

Presenter

Coming soon

BROCHURE  

Request the cGMP Annex 1 Workshop  brochure and find out the latest topics and ideas that will be shared during essential workshop. 

Request

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What our
participants
are saying

I want to extend my gratitude and appreciation for providing such a quality platform for this very important part of our industry! 

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Robert B. Wood IV

Scientist II at FUJIFILM Diosynth Biotechnologies

"We had very interesting discussions with the different participants about our industry and the latest trends. Thanks to Vonlanthen for organizing another great event."

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Paolo Bento

Regional Sales Manager at ILC Dover

"Big thank you to all the speakers at the #5VLHPAPI Summit in Rome. Fantastic insights from a diverse group of industry experts and great presentations from all involved."  

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Jessica Pearson

Occupational Hygiene Consultant at Armstrong Environmental Limited