Cleaning Validation Program Design: Risk-Based Lifecycle Approach
ABSTRACT
This article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA.
KENX’s hybrid conferences highlight those paving the way in best practices in cleanroom qualification, disinfection, contamination control, environmental monitoring and more.
Matthew Jackson
Validation Manager, Torbay Pharmaceuticals
Mr. Jackson is an experienced quality & validation manager with over ten years of experience in all areas of validation including; manufacturing and packing process/product validation, utility & facility validation, CSV, equipment qualification and cleaning validation. Recently appointed as Head of Quality, Matthew looks to promote the use of collaborative and strategic tools, to ensure a successful validation effort. In addition, Matthew has practical experience the use of quality tools for the management of complex validation & quality improvement projects within oral solid dose & sterile manufacturing facilities.
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[/av_three_fourth][/av_section]Mr. Jackson is an experienced quality & validation manager with over ten years of experience in all areas of validation including; manufacturing and packing process/product validation, utility & facility validation, CSV, equipment qualification and cleaning validation. Recently appointed as Head of Quality, Matthew looks to promote the use of collaborative and strategic tools, to ensure a successful validation effort. In addition, Matthew has practical experience the use of quality tools for the management of complex validation & quality improvement projects within oral solid dose & sterile manufacturing facilities.
CIP Cleaning Cycle Development Pitfalls and Solutions
ABSTRACT
Developing an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on developing the automated CIP process for a new facility, but most of the information shared will be useful for all types of cleaning development projects for CIP automated cleaning systems. Semi-automated and manual cleaning applications have either different or additional pitfalls and challenges.
There are several reasons why developing a CIP cycle prior to cleaning validation is often a struggle:
1. High construction management company expectations
2. Non-optimal detergent selection
3. Trusting in legacy cleaning processes
4. Pre-development trail preparedness
5. Weak or non-existent CIP system review
6. Minimalist sampling plan
7. Interdepartmental miscommunication
8. Long lead times
In addition to discussing each reason in detail, the article offers solutions and best practices; so, a CIP cleaning process can be developed with confidence and minimal issues.
Fred Ohsiek
Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North AmericaFred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. His main focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimization. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing. The scope of his work involved drug substance and drug product manufacturing start-up; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution. He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead. [/av_textblock] [/av_three_fourth][/av_section]
Innovative considerations for efficient multi-(product) use of Protein-A columns
ABSTRACT
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan
drug products since the chromatography columns are dedicated per product. In this paper, three innovative
considerations for more efficient use of Protein-A chromatography columns are discussed:
• Evaluating possibilities of extending the lifetime of a Protein-A chromatography column by approaching cleaning as a
process using identified Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) in a computerized
Computer Fluid Dynamics (CFD) model,
• Re-evaluating the sequence of the purification chromatography steps of monoclonal antibodies manufacturing by
incorporating the Protein-A column as the last chromatography purification step which results in benefits from a cost,
cleanability and sustainability perspective, and
• Exploring the possibilities of sharing a Protein-A chromatography column with additional mAb products and steps for
future application. These three considerations can potentially lead to a more efficient use of the Protein-A chromatography
column in mAb manufacturing while reducing the costs of development and manufacturing.
Jennifer Spiegler
Staff Validation Engineer at Janssen Biologics Leiden, the NetherlandsJennifer Spiegeler is Staff Validation Engineer at Janssen Biologics Leiden, the Netherlands. She has 20 years of experience in the Biologics Large Molecule field as she had former positions as QC compliance officer, GMP trainer, Bioprocessing specialist and QA specialist. Jennifer has a Bachelor Degree in Plant Biotechnology from the applied University of Rotterdam and is currently disserting her Master of Science degree at Technical University in Dublin in Pharmaceutical Validation Techniques. She develops strategies for cycle development, qualification, validation and/or verification approaches for large molecule manufacturing (Covid 19 Vaccine and Monoclonal antibodies). She is a cleaning validation expert including development of risk based approaches, soiling assessments, maximum allowable carry-over calculation, development of cleaning cycles, cleaning verification and validation approaches. Next to that, she conducted risk assessments for product contact polymerics and is part of the development of a risk based approach for introducing new polymerics. Currently, she is project lead for scaling up manufacturing of a monoclonal antibody. [/av_textblock] [/av_three_fourth][/av_section]
Medical Product Excursions from Labeled Storage Conditions
ABSTRACT
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution. This document explores how best to reduce the likelihood of stability excursions and how to respond to and analyze the impact of excursions when they occur. Excursion assessment tools and a step by step impact analysis process are included.
John O'Neill
Editor, StabilityHub.comJohn O’Neill is a career-long medical product stability professional with global experience in pharmaceuticals, biologics and medical devices. He enjoys bringing people together to share their stability knowledge through facilitating the Pharmaceutical Stability Discussion Group and as editor of the newly created StabilityHub.com [/av_textblock] [/av_three_fourth][/av_section]
Cleaning Validation
Equipment Grouping
ABSTRACT
Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.
Common industry practice is to either avoid grouping because of perceived risk or base the grouping only on a few physical characteristics (i.e., surface area and vessel size).
Equipment grouping should include equipment geometry and complexity; internal equipment components; piping diameter; and critical cleaning parameters.
The following discussion will explore concepts, considerations, and suggestions for cleaning validation (CV) equipment grouping.
[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Fred-Ohsiek.jpg' attachment='28839' attachment_size='full' copyright='' caption='' styling='' align='center' font_size='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' animation='no-animation' hover='' appearance='' link='' target='' title_attr='' alt_attr='' lazy_loading='disabled' id='' custom_class='' template_class='' av_element_hidden_in_editor='0' av_uid='av-x3ejy' sc_version='1.0' admin_preview_bg=''][/av_image] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Fred-Ohsiek200.jpg' attachment='29189' attachment_size='full' copyright='' caption='' styling='' align='center' font_size='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' animation='no-animation' hover='' appearance='' link='' target='' title_attr='' alt_attr='' lazy_loading='disabled' id='' custom_class='' template_class='' av_element_hidden_in_editor='0' av_uid='av-koasw6bj' sc_version='1.0' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-j0keu' sc_version='1.0' admin_preview_bg='']
Fred Ohsiek
Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North AmericaFred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. His main focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimization. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing. The scope of his work involved drug substance and drug product manufacturing start-up; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution. He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead. [/av_textblock] [/av_three_fourth][/av_section]
Role-based Talent Planning
for
Operational Readiness
ABSTRACT
This paper intends to provide guidance on talent planning, with specific emphasis on role clarity. Given the flurry of activity being conducted during capital projects and transitions to operations, developing a talent plan may appear to be somewhat administrative or insufficiently urgent. This often leads site leaders to forego a focused and thoughtful talent planning process, treating the “people” workstream of Operational Readiness as a purely tactical staffing effort assigned to recruiting and HR and possibly with insufficient ownership from operational workstream leaders.
Harry Benson
Director, Human Performance, CAI
Serving as the Global Director Human Performance Services at CAI, Harry Benson leads a team of experienced professionals in developing and executing programs, processes, and tools with our clients to standardize and improve the performance of their people. A former nuclear-trained submarine officer, he is an expert in organizational culture and structure, along with learning solutions design and delivery with over 20 years of experience in applying current methods for organizational effectiveness within highly technical environments. His methods have driven measurable improvements for a wide range of companies. [/av_textblock] [/av_three_fourth][/av_section]
High Stakes Change Management:
Remediation Post FDA Warning Letter
ABSTRACT
Your company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers between 30-50% (Adam & Danaparamita, 2016; Beer et al., 1990; Kotter, 1995) during normal operations, let alone high stakes environments. Abnormal operating conditions decreases colleagues’ cognitive processing ability and result in behavioral decision making. This combination is dangerous in ambiguous operating environments with underdeveloped cultures. The organization takes social cues from leadership, which influence colleague attitudes based on responsibility and accountability. Leadership’s ability to control stress in the organization preserves resources by reducing tension, providing clarity, making trade-off decisions, and fostering effective two-way communication. Developed leaders know these attributes preserves resources, sustains culture, and leads organizations through high stakes change management environments.
Chris currently serves as a Principal Consultant for CAI, Inc where he provides biopharmaceutical clients with guidance on Organizational and Human Performance. In his past, Chris has led functional elements and multi-site organizations in pharmaceutical, beverage, and the plastics industries. He is a Lean Six Sigma Black Belt, Associate Certified Coach, and currently pursuing his PhD in Industrial and Organizational Psychology from Northcentral University.
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Emerging Technologies in the Pharma
and Life Sciences Industry — Mixed Reality
ABSTRACT
Emerging technologies are quickly playing a greater role in how the Pharmaceutical and Life Sciences Industry collects, stores and interprets its data. Mixed Reality platforms are becoming more widespread in the application of displaying and
interrogating this data. This paper summarises the trials of an initiative supported by KENX USA, TU Dublin and BioPharmaChem Ireland (BPCI). One technology platform, in this case the Microsoft HoloLens 2, was trialled in 3 areas of interest for the industry; namely Remote Equipment Qualifications, Remote Audits & Inspections and Remote Factory Acceptance Testing (FAT).
[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='av-align-top' space='' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' custom_margin='' margin='0px' mobile_breaking='' border='' border_color='' radius='0px' padding='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' highlight='' highlight_size='' animation='' link='' linktarget='' link_hover='' title_attr='' alt_attr='' mobile_display='' id='' custom_class='' template_class='' aria_label='' av_uid='av-8wsqe' sc_version='1.0'] [av_image src='https://kenx.org/wp-content/uploads/2020/05/donncadh-225x300.png' attachment='36554' attachment_size='medium' copyright='' caption='' styling='' align='center' font_size='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' animation='no-animation' hover='' appearance='' link='' target='' title_attr='' alt_attr='' lazy_loading='disabled' id='' custom_class='' template_class='' av_element_hidden_in_editor='0' av_uid='av-kqfw0919' sc_version='1.0' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-j0keu' sc_version='1.0' admin_preview_bg='']
Donncadh J. Nagle
CQV Lead, Jacobs Engineering & Lecturer TU DublinDonnacha J. Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin). Donnacha is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. Donnacha has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donnacha is also a recent winner of the 2018 Thesis award presented by KENX at their C&Q and Data Integrity conference, in Dublin, Ireland. Donnacha is also a published author with IVT/JVT, USA [/av_textblock] [/av_three_fourth][/av_section]
[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/09/Egan-Michael-292x300.png' attachment='25049' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-j0keu' sc_version='1.0' admin_preview_bg='']
Michael S. Egan
Lead Validation Engineer I, Alkermes Pharma IrelandMichael Egan is a Lead Validation Engineer based in Ireland and is currently undertaking the master’s degree programme, MEngSc/PG Dip in Pharmaceutical & Biopharmaceutical Engineering at University College Cork. Michael has over eighteen years’ experience in the pharmaceutical industry. His knowledge extends to all areas of equipment/systems operation and validation including; Equipment & System Qualification, Facility & Utility Qualification, CSV and Process/Cleaning Validation. He has success in the delivery of complex systems and processes through scientific and risk-based methods and approaches and has ambitions to become an industry leader as a technical SME/Design/Principal Engineer. Michael graduated with distinction from the master’s degree programme, MSc. in Pharmaceutical Validation Technology from Dublin Institute of Technology, for which he also won the GetReSkilled Award for “Best overall dissertation performance 2015-16”. Michael also holds a bachelor’s degree in Pharmaceutical Technology from Institute of Technology Tallaght. [/av_textblock] [/av_three_fourth][/av_section]
How to Benefit from the Computer Software Assurance Guidance
ABSTRACT
The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry. Although not yet released, the proposed Computer Software Assurance for Manufacturing, Operations, and Quality System (CSA) guidance will assist manufacturers overcome several barriers to the efficient manufacture of drugs and medical devices. This will be accomplished through the use of implementing critical thinking early in the process, which will guide the verification process rather than using the industry’s current document-centric validation approach. The Computer Software Assurance guidance will provide manufacturers with the FDA’s point of view on the CSA process and will detail how industry can employ the process to verify a computerized system’s installation and operation. This white paper presents a short history of the FDA’s CSV guidance, how it became burdensome to projects, how the CSA approach compares to existing Agency guidance, and it presents steps that can be taken to implement the CSA approach to meet the goal of lowering the cost and duration of CSV efforts.
Brian Stephens
Assistant Director, CSV, CAI
Mr. Stephens is a knowledgeable computerized system validation manager with over 25 years of experience in validating equipment and systems, leading validation projects and teams, and developing lean CSV methodologies for companies and clients. He has utilized his CSV talents to successfully develop and implement CSV remediation programs in response to audits, warning letters and consent decrees, to manage the CSV project for new manufacturing suites and greenfield building constructions, and to manage the implementation of a global validation program. [/av_textblock] [/av_three_fourth][/av_section]
GxP Considerations for Compliance in the Cloud
ABSTRACT
Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has very slow cloud adoption rate. One of the potential reasons for this phenomenon, as highlighted by GAMP Cloud Special Interest Group (SIG ) is the lack of regulatory and industry guidance specific to the subject. Having reviewed the available guidance, this paper proposes the main GxP considerations associated with implementation of a SaaS system, to support GxP process including manage, store, and archive GxP data, and resolves them into a conceptual risk-based model.
Shanmugapriya Shanmugam
M.SC in Pharmaceutical Validation Technology, TU Dublin
Shanmugapriya Shanmugam is an ASQ Certified Software Quality Engineer based in the UK and is currently studying the master’s degree programme, MSc in Pharmaceutical Validation Technology at TU Dublin. Shanmugapriya also holds a bachelor’s degree in Biomedical Engineering. Shanmugapriya has five years’ experience in the medical device industry covering computerised system validation. She has successfully delivered various cost improvement projects and process improvement activities. She also has over four years’ experience in the software industry where she had experience working with cloud based electronic data capture application. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_pc='25' min_height_px='500px' padding='default' custom_margin='0px' custom_margin_sync='true' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_arrow_bg='' id='' custom_class='' template_class='' aria_label='' av_element_hidden_in_editor='0' av_uid='av-17kvae' sc_version='1.0'] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Valerie-Mulholland-300x300.jpeg' attachment='36646' attachment_size='medium' copyright='' caption='' styling='' align='center' font_size='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' animation='no-animation' hover='' appearance='' link='' target='' title_attr='' alt_attr='' lazy_loading='disabled' id='' custom_class='' template_class='' av_element_hidden_in_editor='0' av_uid='av-kd67ihq1' sc_version='1.0' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-j0keu' sc_version='1.0' admin_preview_bg='']
Valerie Mulholland
Senior Director / Principle Consultant, GMP Services LtdFollowing 15 years in the biopharmaceutical industry – on a full suite campus of upstream & downstream biomanufacturing and aseptic filling – she launched a consultancy service in 1997. For over 20 years she has provided Regulatory and Compliance Intelligence, including training & auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries. She has acted as Lead Auditor across a range of manufacturing technologies, suppliers, distributors, and service providers to EU, FDA and International requirements. As a qualified microbiologist, she is comfortable auditing a large range of topics, including quality management systems, quality risk management, data integrity, laboratory controls & analytical methods, microbiology, sterilization, validation, computer system validation, quality improvement projects, and design. She is experienced in pre-PAI and regulatory audit assessment - including MDSAP, Technical File & DHF Assessments and audit coaching & training. she is certified as a Lead Auditor to ISO 13485:2016, ISO 9001: 2015 and MDSAP. She will assure you if you are ready for these or any other regulatory audit. She is secretary of the Irish Chapter of the PDA and have been committed to the organization and moderation of PDA events for many years. As a result, she has extensively networked with regulators and industry experts in emerging or topical areas of interest across the biomanufacturing industry. She participates in the PDA Interest Group on Quality Systems. She is currently researching a PhD in ‘Demonstrating the Effectiveness of Quality Risk Management in the Pharmaceutical Quality System’ and am honored to be mentored by industry leaders on this topic. Her current focus of research is risk based decision making. She is passionate about Risk Management as a broader control strategy. Co-Host the Risk Revolution Podcast with @Journal of Validation Technology. [/av_textblock] [/av_three_fourth][/av_section]
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