A Best Practice Approach For a Compliant Annex 1 Biocide Qualification

Learn about the most important aspects of biocide qualification to minimize workload and comply with the regulator’s expectations. 

August 12


17:00 CEST


Intermediate to expert

Skill Level

1.5 hours





Determining the efficacy of biocides is critical for maintaining the bioburden levels under control to have a safe, robust and reproducible pharmaceutical process. 

However, qualification of biocides is a challenging process, which requires you to consider many parameters and regulatory requirements. Not doing it correctly may lead to contaminations and regulatory complications, which could lead to business shut-down. 


This training will help you consider the most important steps in biocide qualification on the surface and accomplish the authorities’ expectations.

This will ease the work of the operators and SME to understand how the biocide will maintain the bioburden of the facility under control.

Completing this course will help you:

Who is the training for?

The webinar will be highly beneficial to anyone involved in a GMP aseptic production. That includes quality professionals, productions operators, validation experts, Contaminations Control Strategy SMEs, auditors and regulators. 

Play Video


  • Type of microorganisms.
  • Contact time.
  • Log reduction.
  • Cleaning vs disinfection (differences).

We will highlight the keywords of the Annex 1 draft in regard to biocides.

  • Typical standards followed in EU (EN13697, EN 16615)
  • To identify the microorganisms found during the environmental monitoring in critical areas. If not possible, take ATCC standard strains. Do not forget to test Pseudomonas or other water-related microorganism, and fungi.
  • To study the historical data and trending of the microorganisms.
  • surfaces.
  • Contact time
  • Adequate supplier qualification.
  • Acceptance criteria of the biocide efficacy.
  • How many biocides batches to test.
  • Scientific variables to consider.
  • What to do when biocide passes the laboratory qualification.
  • Bad gowning procedure or bad quality of the fabric.
  • Operators training.
  • Biocide concentration mistakes.
  • Residues of biocides not cleaned.
  • Biocides rotations not clear.
  • Poor material transfer.
  • SOPs unclear /not robust.
  • Non robust environmental monitoring.
  • Not respect contact times

About the speakers

Yan Kugel - Qualistery

Yan Kugel

Yan is a GMP quality expert and the managing director at Qualistery GmbH. Through his vision, the company takes complex GMP topics and transforms them into engaging and enjoyable GMP training videos and training programs that captivate the audience. As a result, GMP professionals retain more information, which they can successfully use in their workplace. This is highly beneficial for the employer as for the career of employees.

Marc García Gómez

Marc García Gómez

Marc is an expert on the qualification of disinfectants and sporicides and validation of cleaning and disinfection processes of Pharmaceutical Facilities. Marc is the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. Marc has performed training sessions in dozens of pharmaceutical manufacturing sites about personnel behaviour, hygiene and gowning, cleaning and disinfection of surfaces, Contamination Control Strategy and Risk Analysis following ICHQ9 principles.

What people are saying

Àngels Llarch
Àngels LlarchPharmacist
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Honestly, I thought it would be a kind of refreshment training. Thank you for the quality of the content, the motivation, and for making us vibrate as if we were in the same classroom. ‎
Olivera Tatalovic PMP, CSSGB, Economist
Olivera Tatalovic PMP, CSSGB, EconomistQuality Assurance * Regulatory Projects, Operations & Compliance * EU and MENA region * An alumna of Pfizer & Smith+Nephew
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Thank you Alex Hall and Yan Kugel for one more training with really valuable content provided. I have thoroughly enjoyed it. #qms #qualityassurance
Avanish Kansara
Avanish KansaraQA Manager at Althea
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Thanks Yan & Alex for organising this event. It was great learning and knowledge sharing by Alex and QA experts from all over the world on how CAPA plays important role in improving Quality System. Looking forward for upcoming events to learn other aspects of Quality System and improving myself.
Victoria De La Mare
Victoria De La MareQuality Assurance Specialist
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Yet another very informative session with Alex Hall and Yan Kugel. Extremely useful pointers for change control and deviation management. Thank you once again!
Ramya Raghavendra
Ramya RaghavendraQuality Control Specialist (Stability) at Seqirus
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Thank you, Yan Kugel and Alex Hall for the opportunity to be a part of an amazing and informative webinar with Qualistery GmbH.
Dayna Gabell-Jopson BSc RSci
Dayna Gabell-Jopson BSc RSciQuality Assurance Officer at Bray Group
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Fantastic webinar, very informative, lots of novel ideas and it was run at a good pace. Alex is also very entertaining and makes Quality fun! Thank you Alex Hall, Yan Kugel and Qualistery GmbH #quality #webinar
Jenifer Anigbogu
Jenifer AnigboguQuality Assurance, Regulatory affairs, and Export specialist at Metrovision
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Thank you to Yan Kugel, Alex Hall and Qualistery GmbH for organising this webinar on how to continually improve your quality system - a very engaging and informative presentation.
Sona Ledinia
Sona LediniaFresh Graduate Pharmacist | Passionate and enterprising in being more knowledgeable and skilful in the Pharmaceutical Industry.
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I had a chance to joined a great!, great training webinar by Qualistery GmbH about "How To Take Control Over Your Deviations". Thanks to Yan Kugel, Alex Hall and Qualistery GmbH for giving me this opportunity to acquire such valuable information and mindset to have in maintaining the Quality. Deviations surely the important matter to control so we could get the safest and the best quality we want.
Stefano De Blasis
Stefano De BlasisSite Compliance Specialist (Regulatory Affairs) in Pfizer Italia S.r.l.
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First rule in this dynamic world: Never stop learning! 💪 Thanks to Yan Kugel and Qualistery GmbH for the opportunity to partecipate to this webinar.
Annalisa D'orazio
Annalisa D'orazioQuality Assurance Specialist at GSK
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Another great session about best practices on How to take control over deviations! Very grateful to receive insights on how to reduce the number of reoccurring deviations and improve KPI's, avoiding waste of time and reducing risk. Thanks to Alex Hall Yan Kugel Qualistery GmbH I really invite to have a look on upcoming sessions!
아템켕에드몬드Quality Assurance Manager at Medytox Inc.
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Much appreciation to Yan Kugel and the team at Qualistery GmbH for putting together this training. The training material and manner of presentation was truly unique in its own captivating the audience and naturally increases attention span and concentration through out the session.
Floriana Vetrano
Floriana VetranoChemical engineer
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Thanks Yan Kugel, Alex Hall and Qualistery GmbH for the Great Webinar “ How To Take Control Over Your Deviations” with very useful insight on Issue Management and Recurring Deviations! Well done!
Martina Gjorgjevska
Martina GjorgjevskaQuality Assurance Pharmacist at VARUS
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Thank you all for this great webinar. It was really insightful with great tips to implement in our quality system. Continue with the great work 👏
Nadica Mireva Popovska
Nadica Mireva PopovskaResearch And Development Manager at Galafarm
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Yan Kugel Alex Hall, thank you for the informative webinar. You did a nice job👏
Amritha Mukundan
Amritha MukundanQuality Control Professional
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The training I attended was excellent. The instructor was very knowledgeable and shared great insights that I definitely plan to use. I am looking forward to the next Webinars and Workshops.
Ahmad Al Turman
Ahmad Al TurmanQuality Control Compliance Supervisor at MS PHARMA
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Qualistery has an attractive way to preset their topics. Additionally, the explanations by the trainer were simple and wonderful. I wish you progress and success as I await what comes next.
Miguel Enseñat Mestre
Miguel Enseñat MestreGlobal Production manager and Logistics manager en Labolife España S.A.
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SOPs are the basis for maintaining the consistency and quality of a process, thanks to Qualistery GmbH Yan Kugel and Yogesh Krishan Davé for giving us the opportunity to receive valuable information in a convenient way.

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