Press Room

Event

Webinar - AMLM: the perks of method performance verification in pharmaceutical quality framework

Start
Thursday, October 22, 2020 - 16:00
End
Thursday, October 22, 2020 - 16:00
Location: online

Thursday, October 22nd, 2020 | 12 PM (EDT), 4 PM (BST), 5 PM (CEST)

 

Watch On-Demand Webinar

 

Speakers
Lúcia Volta e Sousa - Analytical Chemist, R&D Analytical Development
Nuno Matos - Director, Quality System Management

 

Analytical Method Lifecycle Management (AMLM) principles require a holistic perspective where method robustness is considered together with process and product variability. AMLM views all method related activities as a continuum and interrelated multi-step process, where knowledge and risk management are the key enablers.

This includes three stages, Method design (Stage 1), qualification (Stage 2) and Performance Verification (Stage 3). All knowledge gathered in Stage 1 and 2 allow an effective definition of the Analytical Control Strategy (ACS), that provides directly the performance parameters that can be continuously monitored on Stage 3. In contrast to the first two stages, Stage 3 offers the possibility of an enhanced data set to collect, analyze and evaluate method performance. This promotes a continuous method evaluation, ensuring it remains fit for the intended purpose or, if not, supports the corrective actions required for method improvement. Moreover, this monitoring program should be aligned with the Quality Management System (QMS) in place, since it includes an efficient change control and deviation management system.

With this webinar an overview of AMLM Stage 3 will be presented, including its implications, advantages and case studies, and its capturing within the current QMS. Additionally, regulatory and industry initiatives that mark the evolution of these concepts and capture the current and future expectation of pharmaceutical framework will be highlighted.

 

In this webinar you’ll learn:

  • Analytical Method Lifecycle Management

  • Method Performance verification program

  • ICH Q14 and Q12

  • USP

 

Watch On-Demand Webinar

 

 

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Three is the magic number for Hovione as it’s once again been certified as a top employer. For the third consecutive year, all four of its manufacturing sites - Lisbon, Cork, East Windsor in USA, and Macau - have been certified as Top Employers by the Top Employers Institute. Hovione is an international integrated pharmaceutical development and manufacturing organisation. This certification follows, Hovione said, a rigorous audit process. Jean-Luc Herbeaux, Chief Executive Officer, Hovione, explained: “This recognition reflects the exceptional dedication and collaboration of the entire Hovione team. Hovione is a development and manufacturing service company operating in one of the most demanding and regulated industries. We understand that our success is deeply rooted in our people. “Together, as One Hovione, we are committed to continuously refining our practices to foster a workplace that inspires motivation and enhances employee satisfaction, so that, every day, our team members bring their best selves to work, driving innovation and excellence at every step,” Jean-Luc added. Ilda Ventura, Senior Vice-President of Human Resources and Member of the Management Board, Hovione, said: “This distinction underscores our unwavering commitment to our people. At Hovione, we design our HR systems and processes to ensure that every team member enjoys a consistent and fulfilling experience, regardless of their role, function, or location.” Imelda Cummins, HR Director for Hovione Ireland, said: “This distinguished accreditation is a testament to our commitment to establish frameworks to attract, engage and retain top talent. We believe that our people are our greatest asset, and this recognition reflects the hard work and dedication of our entire team who strive every day to foster a culture of excellence, innovation, and collaboration. Receiving the Top Employer accreditation is motivation for us to keep pushing the boundaries of what it means to be an exceptional employer.” Hovione recently celebrated the opening of a multi-million euro expansion at its site in Ringaskiddy, which almost doubled the capacity of its spray drying facilities.   Read the full article on CorkIndependent.com  

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Hovione gets top employer accolade

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Hovione has once again solidified its position as a top employer in all four of its manufacturing sites - Lisbon (Portugal), Cork (Ireland), East Windsor (NJ, USA), and Macau. The program highlights the company’s significant advancements in several critical areas, including Purpose & Values, Diversity, Equity & Inclusion (DEI), Employer Branding, and Recognition & Rewards, driven by sustained investment in people. This certification from the Top Employers Institute follows a rigorous audit process and underscores Hovione’s consistency in investing in people and world-class workplace practices, as well as the unwavering commitment of its more than 2,300 employees to the company's core purpose and values.  “This recognition reflects the exceptional dedication and collaboration of the entire Hovione team,” said Jean-Luc Herbeaux, Chief Executive Officer. “Hovione is a development and manufacturing service company operating in one of the most demanding and regulated industries. We understand that our success is deeply rooted in our people. Together, as One Hovione, we are committed to continuously refining our people practices to foster a workplace that inspires motivation and enhances employee satisfaction, so that, every day, our team members bring their best selves to work, driving innovation and excellence at every step.” Macau, which became the first company in the region to achieve Top Employer certification last year, has successfully renewed the status, solidifying Hovione’s global leadership in workplace excellence. With its consistent Top Employer recognition, Hovione demonstrates that the talent strategy is perfectly aligned with the business strategy. Watch Ilda Ventura, Senior Vice-President of Human Resources and Member of the Management Board of Hovione, video about what this certification means for Hovione.   For additional information, please read the press release.  

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