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, 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]How to Benefit from the Computer Software Assurance Guidance
ABSTRACT
Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process is used to substantiate the manufacturing process documents, which contains the control strategy of the drug product and the boundary limits of the process consisting of limits of processing variables. Key process parameters (KPP), critical process parameters (CPP) and critical quality attributes (CQA) are used to define the drug product process control strategy. Validation is performed at the target parameters. All other studies to assess the boundary limits must be done prior to validation.
Mark Moreno
Principal Consultant, CAI
Mr. Moreno has over 34 years of Pharmaceutical Manufacturing experience in aseptic processing, technical service and drug product development; most of which was at Eli Lilly and Company. He developed several drug product dosage forms including oral solutions, Blow-Fill-Seal sterile inhalations and parenteral liquid and freeze-dried presentations: Responsible for devising and performing lab studies to determine the formulation and process leading to clinical supply and final commercialization phases, and supporting process/product boundary parameters. 10 years as a technical service representative for parenterals (small and large molecule dosage forms) with considerable engagement with operations, quality and engineering for continuous improvement and CAPA remediation. Mark is experienced in technical transfer exercises including scale-up activity, master batch record, validation and control strategy design and reports. During his career as a pharmaceutical scientist, he gained considerable knowledge with the formulation of freeze-dried formulations and freeze drying cycle development, including freeze drying microscopy. Experienced in manual visual inspection equipment, inspector qualification and methods for current regulatory expectations. [/av_textblock] [/av_three_fourth][/av_section]
How to Benefit from the Computer Software Assurance Guidance
ABSTRACT
This paper addresses how to qualify a Biological Safety Cabinet(BSC) and includes a description for Installation and Operational Tests that should be included as part of the Qualification process.
Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination. In this case, BSCs, if purchased with much consideration, are the first line of defense in providing personnel, environmental, and/or product protection against biohazards and harmful agents in a range of laboratory, research, clinical, and pharmaceutical settings. As much as selecting the right BSC is important, it is more important to ensure that the BSC is functioning correctly at a high safety level. This white paper provides a template/ description of various Installation Qualification (IQ) and Operational Qualification (OQ) tests that should be included at a minimum when qualifying BSCs to ensure it helps facilitate an optimum working environment.
Wamika Vohra
Commissioning & Qualification Engineer, CAIWamika Vohra is an experienced Commissioning and Qualification Engineer and an ISPE member who received her BS degree in Physical Therapy from India and MS degree in Kinesiology and Exercise Science from California State University, Fullerton. She always had a penchant for life sciences and pharmaceuticals and thus decided to gravitate towards these industries. She has spent the last few years utilizing her diverse background to work passionately in this field. She has worked on a wide range of projects from Gene Therapy, QC Laboratories, to Pharmaceutical Manufacturing Facilities. Wamika is currently working at Commissioning Agents Inc. and has experience working in the pharmaceutical and biopharmaceutical industries. [/av_textblock] [/av_three_fourth] [/av_section]
IS YOUR SITE READY FOR
DATA INTEGRITY?
ABSTRACT
In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater scrutiny. Not all of these observations are driven by the Data Integrity guidance, but the FDA has made it clear that this will be a focus area for inspections in the coming years. What are the basic principles of Data Integrity? How do you ensure that your facility is prepared for an inspection?
Jon Thompson
Principal Consultant, CAIJon is a transformational leader with over 20 years of experience in the Life Sciences. In his 20 years he has worked with a number of companies in the Aseptic Pharmaceutical and Biotechnology space to optimize their operational processes and implement digital solutions to meet regulatory requirements. Jon is experienced with designing and implementing digital systems from Level 2 control to Level 3 business and process solutions. He has lead everything from global programs to standardize automated processes across a network of manufacturing facilities to implementation of a workflow process to automate Engineering Change Requests. He has helped small, clinical scale biotech companies define a digital roadmap to guide them into commercial scale manufacturing and also helped some of the world’s largest pharmaceutical companies define digital solutions to take their operations into the Pharma 4.0 era. Jon’s mission throughout his career has been to apply the principals of Lean and Six Sigma to deliver compliant digital solutions to solve his customers business problems. [/av_textblock] [/av_three_fourth][/av_section]
CPV Batch Record Digitization:
Challenges and Role of AI
ABSTRACT
In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits. In spite of rising demand for the creation of digital data directly at the source itself, some companies follow the traditional methods of documenting the processes parameters on paper, on designed forms. This leads to data being inaccessible for others unless it is again digitized by someone. The traditional way of achieving this is to have someone enter the data into a computer system by shuffling around the pages in the document. The manual process consumes a lot of time and leaves very little time for the data entered to be validated. This article briefly describes the possible methods of automating the manual data entry process, and how the upcoming technologies can be used for this work.
Akash Gajbhiye
Lead Data Scientist, Aventior Inc.Akash Gajbhiye is the Lead Data Scientist at Aventior Inc. He is responsible for design, development and implementation of the Data Science and Artificial Intelligence based solutions. He currently leads all the Machine Learning and Deep Learning based solutions development, across various projects pertaining to Computer Vision and Automated Data Extraction technologies, and is involved in projects with some of the large Bio-Tech firms in the US and satellite operator companies in East-Asia. Akash’s areas of research are in the computer vision and synthetic data generation domains. He comes from an interdisciplinary educational background in applied mathematics, with specialization in Mathematical Modelling and Simulation Development. In the past, he has worked with many R&D and heavy engineering organizations. [/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/2020/07/Abhijit-Ray-e1578588395948.jpg' attachment='24025' attachment_size='full' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Abhijit Ray
CTO And Co-Founder, Aventior, Inc.Abhijit is the CTO and co-founder of Aventior. With over 20 years in technology and working with some of the leading Biotech and Pharma companies, Abhijit has been instrumental is designing new AI solutions for process automation including document processing. Aventior’s solutions for Continued Process Verification and Data Management helps Biotech firms help decrease their efforts in data management, meta-data management and compliance. [/av_textblock] [/av_three_fourth][/av_section]
The Big Reshuffle —
Impact Assessments and System Criticality
ABSTRACT
A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of C&Q – namely impact assessments and system criticality. Have the current challenges been addressed by the update? Does the updated guidance provide clarity on the application of QRM to C&Q? This article explores how these changes bring a modern approach to C&Q.
Laura Butchart
Validation EngineerLaura Butchart is a validation engineer based in the UK and is currently studying the master’s degree programme, MSc in Pharmaceutical Validation Technology at TU Dublin. Laura also holds a bachelor’s degree in Medical and Environmental Microbiology and a City & Guilds Diploma in Steriliser Testing Technology. Laura has over twelve years’ experience in the validation covering IVD, MD and Pharmaceutical industries. She has had success with delivery of projects including start up and capital projects with experience in equipment qualification, facility qualification, computer system validation, process validation and cleaning validation. Laura has achieved varied process improvement activities with application of scientific and risk-based disciplines. [/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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Michael S. Egan
Lead Validation EngineerMichael Egan is a pharmaceutical industry professional based in Ireland and is currently studying the master’s degree programme, MEngSc/PG Dip in Pharmaceutical & Biopharmaceutical Engineering at University College Cork. Michael has over seventeen years’ experience in the pharmaceutical industry. He has success in the delivery of complex systems and processes through scientific and risk-based methods and approaches and has worked in all areas of validation including; equipment & control system qualification, facility qualification, utility qualification, computer system validation, process validation and cleaning validation. Michael’s experience includes extensive knowledge in the operations of a broad range of Oral Solid Dosage equipment and process development/global product transfer in liquid processing including Nano-technology (NCD®) and low-bioburden processing techniques. 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] [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/2020/05/donncadh_nagle.jpg' attachment='159' attachment_size='full' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Donnacha J. Nagle
Validation Consultant & Academic ResearcherDonnacha 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/2020/07/Philip_Jarvis-125.jpg' attachment='23981' attachment_size='full' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Philip Jarvis
Global C&Q Lead, AbbVie
Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologic industries. [/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/alma-223x300.jpg' attachment='25066' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Alma O’Reilly
Validation Manager at LEO Pharma DublinAlma O’Reilly is the Validation Manager at LEO Pharma, Dublin and is a researcher at the Technological University Dublin (TU Dublin). Alma has over 20 years’ experience in the pharmaceutical industry. In that time, she has worked in API, Bulk Process, Fill Finish and Packing Operations. She has extensive experience with automation systems, EBR, serialisation, clean utilities, CSV and equipment, cleaning, and process validation. She is currently heading up LEO Pharma’s drive to standardise C&Q systems and procedures across the group including 5 manufacturing sites. Alma holds an honours degree in Mechanical Engineering, a Master’s degree in Pharmaceutical Validation Technologies and is 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/Phillip-Ison-225x300.jpg' attachment='25057' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Phillip W. Isom
Small Molecule Engineering Strategy and Integration ConsultantPhillip (Phil) Isom is a pharmaceutical industry professional currently based in Ireland with significant global manufacturing experience (USA, Ireland, China, Japan). Phil is a Chemical Engineer by training with over seventeen years of experience in all areas of pharmaceutical manufacturing including; process engineering, quality assurance, engineering leadership, and operations leadership, across multiple technology platforms. He has success in delivering complex global business process changes, including design and deployment of a streamlined global program for equipment qualification. [/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/Siobhan-Griffin-187x300.jpg' attachment='25053' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Siobhán Griffin
Project Engineer at Astellas Ireland Co. Ltd.Siobhán Griffin is a pharmaceutical industry professional based in Ireland and is currently finalising her studies on the Master’s Degree programme, MSc. in Biopharmaceutical Science, a programme which is jointly offered by IT Sligo (the Institute of Technology Sligo) and NIBRT (National Institute for Bioprocessing Research and Training). Siobhan has over ten years of experience in the pharmaceutical industry in the areas of engineering, validation, projects, quality and regulatory affairs. [/av_textblock] [/av_three_fourth] [/av_section]
How to Benefit from the Computer Software Assurance Guidance
ABSTRACT
Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve product realisation, to maintain a state of control, and to facilitate continuous improvement.
ICH Q10 states that the application of QRM can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality. Most of the tools mentioned in ICH Q9, and commonly adopted by pharmaceutical companies, are focused on hazard identification and treatment. These treatments either improve the detection of the risk or reduce the likelihood of its occurrence. A treatment either serves to reposition the risk within a hierarchy or to a more acceptable ranking.
The tool proposed in this paper – The Bow Tie – transfers the focus to the treatments and places the emphasis on the identification and monitoring of prevention barriers, and mitigation barriers in operations environments. This approach develops a clear balance of prevention and mitigation in a risk control strategy.
Valerie Mulholland
Principle Consultant, GMP Services LtdValerie has a deep interest in the future role of the Pharmaceutical Quality System and, in particular, the role of Quality Risk Management (QRM). She is currently researching a Ph.D. with the PRST (Pharmaceutical Regulatory Science Team) in TU Dublin. Her research interest is in developing a model for demonstrating the effectiveness of QRM in manufacturing operations. The Bow Tie article was written in the context of her research on moving the emphasis from reactive to proactive pharmaceutical quality management. www.gmp.ie [/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='rgba(166,53,18,0.18)' 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/shada_warreth-169x300.png' attachment='24492' 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-kd67ihq1' 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' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']
Shada Warreth, BSc, MSc
Senior Bioprocessing Trainer & Training Coordinator; Ph.D. Researcher, TU DublinShada graduated in 2007 from Tallaght IT with a BSc. (Hons) in Pharmaceutical Science where she was awarded with Best Student Placement award. She graduated from Trinity College Dublin in 2010 with an MSc. in Pharmaceutical Medicine. Shada has over three years industry experience from Pfizer Ireland Pharmaceuticals and Gilead Sciences Limited in QC, QA and production/packaging. She has a Certificate in Training and Continuing Education and a Diploma in Business Management and Psychology. She also has a Diploma in Project Management. Shada joined NIBRT in November 2010 and specialises in Aseptic Processing and Fill Finish Operations. Shada is consultant lecturer for Distance (Online) Learning at IT Sligo. Shada is currently pursuing a Ph.D. is the regulation of ATMPs with the PRST (Pharmaceutical Regulatory Science Team) in TU Dublin. [/av_textblock] [/av_three_fourth][/av_section]
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