Novatek

Quality Assurance and Technical Services (QATS) Symposium
2024-10-17 - 2024-10-18
Join Novatek Europe at the QATS Symposium!
We’re thrilled to announce that Novatek Europe will be exhibiting at the Quality Assurance and Technical Services (QATS) Symposium on Thursday, October 17, and Friday, October 18 at Stand 57!
Come visit us at the NHS PASG QATS Symposium to discover how our cutting-edge environmental monitoring and process management solutions can help you achieve your Key Performance Indicators (KPIs). Our tools demonstrate that your production unit or facility is effectively managing your Quality Management System (QMS) and Process Quality System (PQS) in relation to Microbiological Deviations (MDEVs) and Environmental Monitoring Excursions (EMEs).
Let’s explore innovative strategies for streamlining compliance and enhancing proactive contamination control, ultimately improving product quality and patient safety.
Meet our team! We look forward to connecting with industry leaders and experts dedicated to advancing innovation and ensuring patient safety.

The 26th European GERPAC Conference ||| Hyères, France
2023-10-04 - 2023-10-06 | Belambra Business, France
Novatek Europe is thrilled to announce our presence at the 26th European scientific days of GERPAC, taking place on October 4, 5, and 6 in Hyères, France.
We warmly invite you to join us at this highly anticipated event focusing on hospital pharmacotechnics, presented in various engaging formats.
This year’s program features conferences spanning various fields of hospital pharmacotechny. Special attention will be given to 3D printing, risk management in controlled atmosphere areas, and research on extracellular vesicles as non-viral drug carriers.
Attendees can look forward to an enriching European Round Table discussion on business continuity in the aftermath of critical situations. Short oral communications, oral presentation sessions, and a multimedia competition centered around pharmaceutical technology are sure to stimulate innovative thought and discussion.
The event will also feature five interactive workshops in parallel sessions to tackle professional practice topics such as the validation of analytical methods and the establishment of a Cytotoxiq Reconstitution Unit.
Intermissions and exhibition visits will provide valuable opportunities for networking, facilitating conversations between attendees, speakers, and exhibitors.
Recognizing the benefits of accessibility, a remote version of the event will also be available for those unable to attend in person, similar to the successful format offered in 2022. Simultaneous French-English translation will ensure seamless comprehension during all plenary sessions.
We eagerly anticipate the opportunity to meet you at this significant event, whether that’s in-person or during the remote sessions.
Join us for insightful discussions on hospital pharmaceutical technology. We’re looking forward to seeing you there!

FarmForum 2023 ||| Madrid, Spain
2023-09-20 - 2023-09-21 | IFEMA Madrid, Av. del Partenón, 5, Madrid, Spain
Join Novatek Europe at Farmaforum 2023, the preeminent Pharmaceutical, Biopharmaceutical, and Laboratory Technologies Industry Forum, set to hold its ninth edition in Madrid at the Feria de Madrid’s Hall 14.
Over the years, Farmaforum has solidified its reputation as the most significant event for the Pharmaceutical Industry in Spain. It continues to broaden its thematic focus, establishing synergies with the Biotechnology and Cosmetics Industries through specialized areas such as the Health&Research Forum, Cosmeticsforum, Biotechforum, Nutraforum, and Cannabisforum.
Farmaforum boasts an exhibition area complemented by a comprehensive program of conferences and workshops, featuring dedicated spaces for networking. We’re excited to be part of the event that, in 2023, will also host the fifth edition of Labforum – a specialized event dedicated to Materials, Instrumentation, Equipment, and Methods for Laboratory Analysis and Diagnosis.
As a side event running parallel to Farmaforum, Labforum provides a unique focus on the new generation of research and analytical laboratories. Further enhancing the forum’s offerings, the incorporation of the Health&Research Forum congress will bring the world of research to the fore.
The pharmaceutical, biotechnology, and cosmetics industries, to name a few, hinge on the progress of research for their product launches. Speeding up these processes while ensuring quality and safety has a direct bearing on the costs of new development, making it a matter of utmost importance for companies.
Be part of this extraordinary event with NOvatek Europe. Engage with industry leaders, discuss breakthroughs, and gain insight into the cutting-edge technologies shaping the future of these industries. We look forward to seeing you there!

Quality Risk Management An ICH Q9 Training Course
2023-09-06 - 2023-09-07 | Barcelo Sants Hotel, Pl. Països Catalans, Barcelona, Catalunya, Spain
Join Novatek Europe at ECA Quality Risk Management An ICH Q9 Training Course

Speakers

Alexandra Bauloye, GSK Belgium
Christof Langer, OSConsulting, Austria
Aidan Madden, FivePharma, Ireland
Dr Franz Schönfeld, GMP Inspector, Germany

Objectives

This ECA training course deals with the practical implementation of Quality Risk Management (QRM). You will learn how to implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators.

Background

The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].
QRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline, which has been incorporated in the EU-GMP Guidelines, Part 3. In the course of implementing ICH Q9, risk-based approaches increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail. Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.

Target Group

This training course is designed for members of staff in pharmaceutical, biopharmaceutical and API industry’s production and quality units, who establish, manage and use quality risk management systems.

Programme

ICH Q 9 – Quality Risk Management: an Overview

QRM in non-GxP industries
QRM in pharma
Historical GMP Situation
ICH Q9: current Revision
QRM tools and techniques

The Inspector’s View

Expectations
Integration in the Pharmaceutical Quality System
Examples for good and not so good practice

How to realise Quality Risk Management in a GMP Environment

The term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice on how implement QRM:
– Chapter 1
– Chapter 2
– Annex 1
– Annex 15
– Annex 16
SOPs needed
Auditing

Interactive Session: Applying Principles of QMR after an Incident has happened
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.

Design of an Event Handling System based on a Quality System and Quality Risk Management Approach

QRM in the Quality System
Design of an Event Handling system based on QRM and Management Review
Use of QRM in the evaluation of Events
Examples

Case Study: Quality Risk Register

What is it, how to develop it and which type of risks to include
What to show to authorities?
The way to business continuity
Examples

How to implement Quality Risk Management in a pharmaceutical Company

Part 1: QRM Tools made practicable in daily life
– ICH Q9 and other Norms (with takeaways for Pharma)
– Strength of practical DMAIC methodology
– QRM culture: principles and examples
– Cost of Quality/Compliance
Part 2: Examples
– Change Control
– Monitoring
– Maintenance

Days until Annex 1 deadline
2023-08-25

2023 ISPE Biotechnology Conference ||| Dublin, Ireland
2023-06-27 - 2023-06-28 | Clayton Hotel Burlington Road, Upper Leeson Street, Dublin, D04 A318, Ireland
We are excited to announce that Novatek Europe will be exhibiting at the 2023 ISPE Biotechnology Conference in Dublin, taking place from 26-27 June 2023.
This significant event provides an all-encompassing perspective on the development and manufacturing of biotechnology products, making it a must-attend for industry professionals.
This conference places emphasis on the power of process intensification in boosting production yields. By exploring strategies such as flexible facility designs, modular concepts, and collaborative project delivery, it aims to significantly reduce costs, expand plant capacity, and optimize production time.
The ISPE Biotechnology Conference will concentrate on the unique challenges surrounding innovative, biosimilar, and subsequent generation biotechnology products, such as cell and gene therapy, Advanced Therapeutic Medicinal Products (ATMPs), and mRNA-based products. This includes discussions on accelerating market entry, reducing submission approval times, managing product technology transfer, and pioneering concepts for control strategies, quality oversight, manufacturing, and logistics.
The conference will focus on learnings from innovative pharmaceutical products and their application to biosimilar, bio-better, and follow-up biotechnology products. Methodological enablers for process development, supply chain resiliency, and sustainability will feature prominently. All discussions will be presented within the current regulatory framework.
Providing an interdisciplinary platform, the conference invites all stakeholders of the pharmaceutical and biopharmaceutical supply chain to present recent innovations, trends and engage in open discussions on technical, logistical, and regulatory challenges and solutions.
The evolving regulatory environment’s impact, the need for continuous innovation, and supply chain continuity will be integral to the conference programme and panel discussions. Participants will have the unique opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.
Join Novatek Europe at this groundbreaking event and take part in shaping the future of biotechnology. We look forward to seeing you there!

6th Aseptic Processing Summit ||| Vienna, Austria
2023-06-21 - 2023-06-22 | Meliá Vienna, Donau-City-Straße 7, Vienna, Austria
Novatek Europe is delighted to announce our participation as exhibitors at the 6th Aseptic Processing Summit taking place on June 21-22, 2023. As demand for aseptic manufacturing continues to surge, the complexity of aseptic processing challenges grows concurrently, a topic this summit is set to tackle head-on.
The recent amendments to Annex 1 have introduced new hurdles for pharmaceutical companies to overcome. These challenges span both technical and organisational aspects, demanding novel approaches and solutions.
At the summit, industry experts will shed light on the essentials for robust aseptic processing and provide targeted implementation strategies. Particularly, there will be shared insights on establishing aseptic manufacturing processes for Advanced Therapy Medicinal Products (ATMPs) and vaccines. The event will also delve into the adoption of innovative aseptic processing technologies, including the integration of robotics in aseptic processes.
Don’t miss this opportunity to join Novatek Europe at the 6th Aseptic Processing Summit, where we’ll be part of discussions that will shape the future of aseptic processing. We look forward to connecting with you at this critical event!

European GMP & GDP Forum ||| Barcelona, Spain
2023-06-20 - 2023-06-22 | Barcelo Sants Hotel, Pl. Països Catalans, Barcelona, Catalunya, Spain
Get set to join Novatek Europe at the much-anticipated combined European GMP Conference and European GDP Forum! We are thrilled to announce our participation as exhibitors in this compelling event which has been offering insights on GMP and GDP for years. Now in its latest format, the forum provides an exceptional opportunity to learn about the challenges across the entire pharmaceutical supply chain, directly from industry experts and authorities.
This year, we’re excited to welcome you back to in-person networking and learning. The Forum will be held as an on-site event, offering the much-missed opportunity for face-to-face interactions.
This carefully designed three-day event has been structured to meet your individual needs and interests.
Day 1 will focus on GMP topics, Day 2 will blend both GMP and GDP discussions, and the final day will be solely dedicated to GDP subjects.
You have the flexibility to attend the forum for just one, two, or all three days, tailoring your experience to your professional needs.
In June 2023, the forum promises a rich selection of speakers from Regulatory Authorities and the Pharmaceutical Industry. They will share and stimulate discussion on the latest GMP & GDP developments, offering invaluable insights to keep you at the forefront of industry advancements.
Join Novatek Europe at this landmark event, and let’s explore the future of GMP & GDP together. We can’t wait to welcome you on-site!

2nd ANNUAL EXCELLENCE IN CLEANROOM SERVICING & MAINTENANCE ||| Barcelona, Spain
2023-06-19 - 2023-06-20
Mark your calendars for an industry-focused event that promises to revolutionize your cleanroom operations! Novatek Europe is delighted to announce our participation as exhibitors in the upcoming conference on Cleanroom Equipment Maintenance, hosted by TBM. This event is your perfect platform for learning, networking, and exploring the best practices in cleanroom maintenance and servicing.
Consistent and meticulous maintenance is crucial for the optimal performance of your cleanroom equipment, ensuring compliance, process efficiency, and reliability while minimizing downtime and reducing operating costs. However, achieving this balance requires strategic planning to limit disruption, and combining tasks effectively to maximize productivity.
Drawing on their vast experience in organising events focusing on Cleanroom Design, Engineering, Operations, QA, and QC, TBM now introduces a forum dedicated to cleanroom maintenance and servicing. This conference aims to empower attendees with comprehensive insights on critical topics such as:

The crucial role of cleanroom servicing and maintenance at the design and engineering stage.
Effective cleanroom remediation strategies post-contamination events.
Maintaining complete control of the cleanroom environment through diligent management of servicing and maintenance functions.
Best practices in cleanroom equipment servicing and maintenance.
Optimizing preventive maintenance strategies for your cleanroom.
The complexities of fine-tuning HVAC systems.
Upholding the highest levels of training and quality for cleanroom servicing and maintenance personnel.
Energy efficiency strategies in challenging times.
Best practice in risk identification, mitigation, and management.
Cleanroom validation strategies for comprehensive monitoring and maintenance of cleanroom environmental quality.
Ensuring awareness and compliance with evolving regulations and standards.

Join Novatek Europe at this enriching conference and equip yourself with the knowledge and strategies needed to optimize your cleanroom maintenance. We look forward to meeting you there and exploring the future of cleanroom operations together!

PHSS Sterile product manufacturing conference & Aseptic Processing workshop 2023 ||| Birmingham, UK
2023-06-13 - 2023-06-14 | Moor Hall Hotel & Spa, The Royal Town of Sutton Coldfield, Birmingham, Sutton Coldfield, B75 6LN, United Kingdom
Get ready to elevate your industry expertise! Novatek Europe proudly announces our participation in a dynamic and indispensable event, a merger of two premier happenings in the pharmaceutical industry calendar: The Sterile Product Manufacturing Conference and the Aseptic Processing Workshop. Focused on the critical application and understanding of the revised EU GMP Annex 1, this comprehensive event is an opportunity you don’t want to miss.
At the core of the conference, a distinguished panel will deliberate the inherent challenges in Annex 1 implementation, a topic essential to the sphere of sterile product manufacturing. The conversation will encompass strategic planning, justifications for extensions beyond the Annex 1 enforcement date (25 August 2023), and vital mitigation measures to aid transition periods.
The event is not just an exposition, but a thorough guide through the process of identifying gaps in compliance, establishing robust control measures and documenting all these efforts in a Contamination Control Strategy (CCS).
We encourage attendance from all professionals involved in implementing GMP compliance to Annex 1. Furthermore, those establishing an improved Quality Risk Management (QRM) in line with the latest revisions of ICHQ9(R1) QRM guidance, or adopting Life Cycle strategies considering ICHQ12, will greatly benefit from this event.
With the Annex 1 enforcement date looming on 25 August 2023, there’s no time like the present to ensure your readiness and compliance. Benchmark your efforts, challenges, and strategies for compliance with other industry stakeholders. The opportunity to gain such crucial insights and networking prospects is one that should not be missed.
Join us and seize the chance to propel your industry knowledge and practice to new heights!

PDA Ireland Chapter: Visual Inspection
2023-05-19

BioPharma & Lifesciences Connected. Cork, Ireland
2023-01-25 | Radisson Blu Hotel & Spa, Ditchley House, Castleview, Little Island, Co. Cork, Ireland, Cork, WJ4R+7W, Ireland
Key Topics Include
· Research & Innovation
· Robotics & Automation
· Vaccine Manufacturing
· Process Optimization
· Sustainability
· Digitalization
· IoT & Industry 4.0
· Covid 19 – Impact to the market
· Hybrid Systems – Single Use and/or Stainless Steel
· Ultrafast Project Execution
· Capital Investment Project Controls
· HVAC & Cleanroom Engineering
· Cell & Gene Therapy

KENX: VALIDATION & GMP UNIVERSITY EUROPE
2022-11-21 - 2022-11-23 | The Spencer, Excise Walk, IFSC, Dublin, D01 X4C9, Ireland
Join Novatek at KENX’s Validation & GMP University Europe Conference!
November 21-23rd virtually and in Dublin, Ireland

Do not miss this opportunity to network with leading experts and like-minded colleagues leading the charge for best practices in validating processes, cleaning, equipment, facilities, utilities, quality systems & metrics, change control, risk management, inspections and so much more!

This is your opportunity to register and save $200 with code SPEAK200 at the link below:
Register HERE

PDA Ireland - Annex 1: Overcoming Challenges in Implementation
2022-11-11 08:00 - 17:00 UTC | Castleknock Hotel, Porterstown Rd, Diswellstown, D15, Ireland, D15 WNR7, Ireland
Novatek Europe will attend this event:
EU GMP Annex 1 has been issued! Join PDA Ireland on 11 Nov 2022 where overcoming challenges in implementation will be discussed.
https://www.eventbrite.ie/e/annex-1-overcoming-challenges-in-implementation-tickets-414547451587

PHSS Annex 1 Discussion forum
2022-10-20 09:00 - 17:00 | London Heathrow Marriott Hotel, Bath Road Heathrow Airport, Hayes, London, UB3 5AN, United Kingdom
Discussion forum moderators:
Di Morris PHSS Co-Chair, James Drinkwater (Ex-Chairman, honorary member)

Objectives of the Annex 1 discussion forum and intended outcomes
Overview of key updates in Annex 1 from version v12 that was the subject of a targeted consultation process with PHSS as one of the (12) EC appointed Targeted commenting platforms through to the final publication on 25 August 2022 that goes a long way to addressing industry concerns, but still issues of clarity remain.
Insight to how the discussion forum will be managed.

Important Quality related concepts that are fundamental to the revised Annex 1

The paradigm shifts in GMP regulations to Risk based, holistic and proactive methodologies and international relevance of Annex 1.

Risked based with QRM as a fundamental principle

Holistic considering collective effectiveness of control measure across interrelated areas and operations.

Proactive with data-based knowledge, trending and reviews that drive improvements over the product Life cycle (ICHQ12).

Discussion sessions

Contamination Control Strategy (CCS) insight to expectations and PHSS guidance to assist preparation.

Break for refreshments

Session 1: Annex 1 sections 1; Scope, 2; Principle, 3; Pharmaceutical Quality System (PQS).

Break for Lunch

Session 2: Annex 1 sections 4; Premises, 5; Equipment, 6; Utilities

Short break

Session 3: Annex 1 sections 7: personnel, 8: Production and specific technologies

Afternoon Break

Session 4: Annex 1 sections 9; Environmental and process monitoring, 10: Quality Control, Glossary

Thanks, closing statement and discussion close.

SPEAKER: 2022 PDA Annual Meeting
2022-08-01 - 2022-08-03 | Hyatt Regency Dallas
Level Up: Agility in the New Normal
This Conference will focus on the theme to Level Up: Agility in the New Normal! We will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.
ASEPTIC PROCESSING & STERILIZATION SPEAKER:
DAY 2: Tuesday April 5, 2022
Strategies for Total Contamination Control in an Aseptic Environment

Sheba Zaman, Head of Product Specialists and Training Services, Novatek
Come also see us at BOOTH 406 in the Exhibitor Hall!
