Commissioning, Qualification & Validation

23rd-24th October 2019, Copenhagen By ValidEire ApS and Key2Compliance, sponsored by Novatek International   SUMMIT DESCRIPTION This two-day conference put focus on Science, Risk and Statistics-based Cleaning Process Development and Validation. Presentations will be given on standards, analytical methods and use of statistics to cleaning validation development, risk evaluation, Swab Recovery, data integrity, variability, what’s coming and much more.   AGENDA Day 1 – 23th October, 2019 Day 2 – 24th October, 2019 08:30 Breakfast & Networking 08:30 Breakfast &…

10th September 2021, Copenhagen   WORKSHOP DESCRIPTION Sharing, learning, and networking in a robust network of Process Validation Specialists.   AGENDA 09:00 – Breakfast 09:30 – Intro 09:40- Round the table 09:45- Doing Digital or Being Digital – Marc Vordermann 10:15- ASTM E2500- Jesper M. Wagner 10:45 Plenary Q&A 11:00 Intro to workshop 11:15 LUNCH 12:15 Workshop 1 / Workshop 2 13:45 Break & Snacks 14:10 Workshop 3 15:00 Wrap-up   SPEAKERS Jesper Wagner, AlfaNordic Marc Vorderman, Novatek International Laurence…

14th-15th June 2022 at DGI Byen, Copenhagen A collaboration between Key2Compliance and ValidEire ApS   SUMMIT DESCRIPTION This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of aseptic manufacturing. Attendees will therefore gain a deeper understanding of the new messages from the new Annex 1 draft, FDA focuses on inspecting sterile facilities,…

25th-26th April 2023 at DGI Byen Conference Center, Copenhagen A collaboration between ValidEire ApS and Key2Compliance   SUMMIT DESCRIPTION Cleaning and Sterilization processes related to production equipment need to meet the standards of the authorities where the control and reduction of chemical, microbial, particulate and endotoxin/pyrogen contamination is  considered important. Any contamination control strategy requires an evaluation of these controls based on risk and risk assessment. Whether you work with Pharmaceuticals or Medical Devices, you are witness to a raised focus…

10th-11th September 2024: Cleaning in Place (CIP), Sterilisation in Place (SIP), and Environmental Monitoring (EM) Location: Park Bio, Østerbro, Østerbrogade 79, 2100 København Ø, Denmark. Price: € 1.395,- DKK 9.995,- Early Bird: Get 15% off before June 15th. Live streaming option: € 495,- DKK 3.399,- If you don’t have the possibility to join us physically in Copenhagen, we offer an online option where you can join sessions and Q&As via live video.  Register & Pay SUMMIT DESCRIPTION The summit model…