Novatek

2nd ANNUAL EXCELLENCE IN CLEANROOM SERVICING & MAINTENANCE ||| Barcelona, Spain
2023-06-19 - 2023-06-20 | Sutton Coldfield
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 | Sutton Coldfield

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!
