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/Donnacha-Nagle-KENX-photo-002.jpg' attachment='30461' 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-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='']
Donnacha J. Nagle
CQV Lead, Jacobs Engineering & Researcher 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/vallerie_muholland-237x300.jpg' attachment='24491' 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='']
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]
Drug Product Validation
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]
Biosafety Cabinet Qualification
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 several companies in the Aseptic Pharmaceutical and Biotechnology space to optimize their operational processes and implement digital solutions to meet regulatory requirements. He has led 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 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]
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