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GMP UNIVERSITY – CHANGE CONTROL

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Make Key Decisions Based on Effectively Managing Risks in Your Quality System

August 19 - August 21

San Diego, United States



Implement Procedures and Discover Techniques that Have Immediate Impact

 

Managing changes in your Quality Management System is a FDA regulatory requirement and is one of the top issues cited in Warning Letters. KENX is excited to announce a conference the can dramatically CHANGE your strategy surrounding your change control program. KENX’s Change Control conference provides the knowledge and tools to develop, implement and maintain best-in-class procedures that impresses FDA investigators and makes an immediate impact to your organization and professional career. This program guides you through the process of developing, implementing and maintaining an effective change control program enterprise-wide.

 

Top 10 Reasons to Attend:

  • Know the regulations, guidance and warning letters
  • Build and manage a program that is inspection ever-ready
  • Recruit and train your change control committee
  • Learn how to use risk management and conduct impact assessments
  • Change control and configuration management
  • Discover documentation practices and effective quality management software
  • Identify and classify changes
  • Implement post approval change control protocols
  • Handle deviations in change control processes
  • Perform a quality system gap assessment

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.

 

Send Your Team! This Event is Co-located with:

Quality Risk Management

Internal Audits and FDA Inspections

Agenda

  • 12:00
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:00 PM
    Chairperson’s Welcome and Opening Remarks
  • 1:15 PM
    The Butterfly Effect – Understand the Interrelationship Between Audits, Change and Risk
    Carmen Medina, MPH, Ph.D. (c), President, Precision Consultants, Inc., Coronado, CA, Former FDA Investigator
  • 1:45 PM
    Apply Risk Management throughout Your Quality System – Where, When and How
    Patrick Mains, Principal Quality Engineer, Genentech
  • 2:00 PM
    Understand the Impact of Human Errors in Your QMS
    Matthew LaPierre, Industry Expert
  • 3:00 PM
    Afternoon Refreshment Break
  • 3:30 PM
    Integrate Quality Risk Management (QRM) into Commissioning & Qualification (C&Q)
    Chip Bennett, QRM and CQV Program Development, CAI
  • 4:00 PM
    Quality Management System (QMS) Inspection Readiness – Five Best Tips
    Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, Temple
  • 4:30 PM
    Staying Ahead of the GMP Regulatory Curve through Inspection and Enforcement Data
    Michael de la Torre, CEO, Govzilla
  • 5:00 PM
    Close of Day One & Welcoming Network Reception
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM
    Select Between Knowledge Exchange Sessions (1-3)
  • Change Control
    FDA Warning Letters Related to Equipment and Utility Changes
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • Risk Management
    Pitfalls in Quality Risk Management – Top Five Most Common Errors
    Lori Richter, Senior Consultant, ValSource
  • Audits & Inspections
    Using FDA Inspection and Enforcement Data to Improve Internal and External Audits
    Julie Maurhoff, Senior Director Compliance, Ultragenyx
  • 8:30 - 10:00 AM
    Select Between Knowledge Exchange Sessions (4-6)
  • Change Control
    Establish Good Documentation Practices for Change Control
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • Risk Management
    Customizing Risk Analysis for the Future
    Eric Henry, Senior Quality Systems & Compliance Consultant, King & Spalding LLP
  • Audits & Inspections
    Build an Audits and Inspections Program from the Ground Up
    Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, Temple
  • 10:00 AM
    Networking Refreshment Break
  • 10:30 AM - 12:00 PM
    Select Between Knowledge Exchange Sessions (7-9)
  • Change Control
    Build a Change Control Program from the Ground Up
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • Risk Management
    Use Statistics as a Risk Management Tool
    Tara Scherder, Partner, SynoloStats
  • Audits & Inspections
    Build and Manage Your Audit Team
    Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, Temple
  • 12:00 PM
    Lunch & Learn Sessions (10-12)
  • Change Control
    Conduct an Audit of Your Change Control Program
    Abigail Davis, MS, Senior QA Manager, Quality Systems, Promega
  • Change Control
    Pitfalls in Change Control – Five Common Challenges
    Mehron Mirian, Senior QA Manager, Molecular Templates
  • Risk Management
    ICH Q9 – The QRM Lifecycle Foundation
    Tara Scherder, Partner, SynoloStats
  • Audits & Inspections
    WHO GMP Global Inspection Readiness
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 1:15 - 2:45 PM
    Select Between Knowledge Exchange Sessions (13-15)
  • Change Control
    Change Control for Computer Systems and Software Upgrades
    Chinmoy Roy BSEE, MSCS, Data Integrity and CSV SME, ValGenesis
  • Risk Management
    Build a QRM Program from the Ground Up
    Peter Ackerman, Senior Quality and Regulatory Consultant, NAMSA
  • Audits & Inspections
    Integrate Risk Management into Audits
    Ravi Samavedam, General Manager, Azzur Group LLC.
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15 - 4:45 PM
    Select Between Knowledge Exchange Sessions (16-18)
  • Change Control
    Conduct an Impact Assessment as Part of Change Control
    Alan Golden, MS, Principal, Design Quality Consultants, LLC
  • Risk Management
    Data Tracking and Monitoring of Outputs of Risk Assessments
    Chip Bennett, QRM and CQV Program Development, CAI | Aaron Roth, QRM and CQV Program Development, CAI
  • Audits & Inspections
    Conduct a Data Integrity Audit Enterprise-Wide
    Matthew LaPierre, Industry Expert
  • 4:45 PM
    Close of Day Two
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM
    Select Between Knowledge Exchange Breakfasts (19-21)
  • Change Control
    Validate and Manage Changes for Cloud Applications
    Chinmoy Roy BSEE, MSCS, Data Integrity and CSV SME, ValGenesis
  • Risk Management
    Risk Ranking and Filtering for Risk Identification
    Peter Ackerman, Senior Quality and Regulatory Consultant, NAMSA
  • Audits & Inspections
    Pitfalls in Audits & Inspections – Top Five Most Common Errors
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • 8:30 - 10:00 AM
    Select Between Knowledge Exchange Workshops (22-24)
  • Change Control
    Quality Process Management for Change Control
    Camille Denoga, Global Head of Change Control, Takeda (Invited)
  • Risk Management
    Prepare for a QRM-Focused Inspection
    Lori Richter, Senior Consultant, ValSource
  • Audits & Inspections
    Inspection Readiness—Conducting a Mock Inspection
    Ravi Samavedam, General Manager, Azzur Group LLC.
  • 10:00 AM
    Mid-Morning Refreshment Break
  • 10:30 AM - 12:00 PM
    Select Between Knowledge Exchange Workshops (25-27)
  • Change Control
    Present Your Change Control Program to an Inspector
    Camille Denoga, Global Head of Change Control, Takeda (Invited)
  • Risk Management
    Create and Use a Custom Risk Tool
    Randy Friedman, Principal Quality Risk Management Specialist, Genentech
  • Audits & Inspections
    Interactive Master Class – Build Your Custom Audit Checklist
    Mony Clark, Senior Specialist, Quality Compliance, Bayer Pharmaceuticals
  • Audits & Inspections
    Challenges Around Maintaining Audit and Inspection Readiness
    Ken Lance, Inspections Specialist
  • 12:00 PM
    Lunch and Learn Sessions (28-30)
  • Change Control
    Handling Post Approval Change Control Protocols
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • Risk Management
    Successful FMEA Training – Training, Tools and Continual Improvement
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • Audits & Inspections
    Bridge Communication Between Quality and Operations
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • 1:15 - 2:45 PM
    Select Between Knowledge Exchange Sessions (31-33)
  • Change Control
    Harmonize Change Control Processes and Programs Enterprise-wide
    Abigail Davis, MS, Senior QA Manager, Quality Systems, Promega
  • Risk Management
    Implement Risk Management into Computer Systems Validation
    Senthil Gurumoorthi, MS, MBA, Associate Director, IT, Gilead Sciences | Ken Shitamoto, MS, Senior Director, IT, Gilead Sciences
  • Audits & Inspections
    Root Cause Analysis (RCA) and Corrective Action (CAPA)
    Mony Clark, Senior Specialist, Quality Compliance, Bayer Pharmaceuticals
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15 - 4:45 PM
    Select Between Knowledge Exchange Sessions (34-35)
  • Change Control & Risk Management
    Integrate Risk Management into Change Control Processes
    Alan Golden, MS, Principal, Design Quality Consultants, LLC
  • Audits & Inspections
    Observations and Responses – Successful Interpretation and Writing Responses
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • 4:45 PM
    Close of Conference

Faculty

  • Peter C. Ackerman, Principle Medical Research, Manager, Quality Systems - IVD

    Peter has been in the industry (25+ years) with (15 years focused on IVD and companion diagnostics) and is working with Invitrogen and Life Technologies (now ThermoFisher Scientific) developing the organizations Quality Management System for IVDs and medical instrumentation, specifically design controls, R&D software development/release, QA release, systems validation, risk management and supplier quality, attaining alignment to US and OUS regulatory agencies. Peter has consulted to Fortune 500 Life Science companies, i.e, JnJ (DepuySynthes, Ethicon & Cordis) Roche Diagnostics, Abbott, midsized organizations (FisherPaykel, Talecris Biotherapeutics, eTherapeutics, 5D information Systems, Amgen) and with multiple emerging technology companies.
  • Chip Bennett, SME, QRM and CQV Program Development, CAI

    Mr. Bennett is a PMI® Certified Project Management Professional (PMP) with 19 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.
  • Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute

    Ms. Joscelyn Bowersock is a Quality and Regulatory Manager with nineteen years of clinical and research experience; including process implementation and validation, risk mitigation protocols, facility commissioning, and master file development. Her experience has allowed her to successfully implement numerous quality systems, navigate IND submissions, FDA inspections and cell therapy program accreditations.
  • Mony Clark, Senior Compliance Specialist and Lead Auditor, Bayer Pharmaceuticals

    Ms. Mony Clark is a Senior Compliance Specialist and Lead Auditor at Bayer Pharmaceuticals where she is responsible for managing the Internal Audit Program. In addition, as a qualified Risk Facilitator, Ms. Clark supports risk assessments and offers her specialized assistance in external audits for Supplier Management. In Mrs. Clark's experiences in both Medical Devices and Pharmaceutical industries, she has guided companies through gap assessments, transitioning them from research and development to GMP compliant manufacturing facilities. For the past 12 years, Mrs. Clark has managed Quality Systems, and audit programs, demonstrating a proven track record of leading several companies through successful inspections, including Pre-Approval Inspections and ISO accreditations.
  • Camille Denoga, Global Head of Change Control, Takeda

    Ms. Denoga is an experienced team leader with over seventeen years of experience in quality including QC Microbiology with a focus on aseptic practices and contamination investigations and responsibility for oversight of the Quality Management Systems at the facility and corporate level.
  • Randy Friedman, Principal Quality Risk Management Specialist, Genentech, Inc.

    Randy is responsible for the design, development, sustainment and governance of a harmonized GMP compliant Quality Risk Management program across the Roche global network. He routinely provides QRM expertise, training in QRM concepts and tools, and facilitates best practice network wide sessions for use of QRM in the Quality System.
  • Alan Golden, MS, Principal, Design Quality Consultants, LLC

    Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
  • Senthil Gurumoorthi, Associate Director, Gilead Sciences

    Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally. He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London.
  • Eric Henry, Senior Quality Systems & Compliance Consultant FDA & Life Sciences Practice, King & Spalding

    Eric Henry is a Senior Quality Systems and Compliance Consultant in the FDA and Life Sciences legal practice of King & Spalding. In this role, Eric provides advisory and hands-on support to management and staff to firms in the life sciences industry, as it relates to large process improvement initiatives, the defense of quality systems to third parties (e.g. FDA, notified bodies, CFDA), quality system remediation programs (including under FDA enforcement actions), and merger / acquisition due diligence. Eric has 28 years of experience in global quality and compliance roles (16 years in medical device leadership), with a specialization in software quality (including cybersecurity), medical device design controls, risk management, audit management, and management controls.
  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30 years of experience in the Quality System environment, strategic drug development and stability sciences. She is a Council of Expert of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel as well as the former chair of the USP Good Documentation Practices Expert panel. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology where she teaches Quality Audits, GMPs, ICH Quality Guidelines and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks; “Handbook of Stability Testing of Pharmaceutical Products” and “Stability Testing to Support Global Markets.”
  • Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology

    Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.
  • Ken Lance, Audits and Inspections Specialist

    Mr. Lance brings over 23 years of experience in the Biotech field working in the Clinical and Commercial Manufacturing, Product Development and Quality space. He is an innovative Quality Engineer with expertise in medical devices and combination products, utilizing extensive program management and product development skills and experience.
  • Matthew LaPierre, Industry Expert

    Mr. LaPierre is an experienced data integrity program manager and industry expert in the field. He has a thorough understanding of not only the foundation and principles of data integrity, but the project management tools and resources needed to execute a truly effective data integrity program at a pharmaceutical site.
  • Patrick Mains, PMP, Principal Quality Engineer, Global Quality Risk Management

    Patrick is responsible for the design, deployment, realization and governance of a harmonized GMP compliant Quality Risk Management (QRM) Program for the Roche global network. He routinely provides training, leadership, QRM expertise and facilitation for complex risk management efforts. Patrick has a background in Pharmaceutical Quality Control which he leverages to support the organization in QRM implementation.
  • Julie Maurhoff, Senior Director of GxP Compliance and Inspection Readiness, Ultragenyx Pharmaceutical

    Julie Maurhoff is a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical. She is an ASQ Certified Quality Auditor and Quality professional with over 25 years of industry experience spanning Quality Operations in Biotech, Food and GLP, including Technical Recruiting and Talent Placement. She has spent the past 15 years focused on Domestic and International GMP Auditing, preparing internal and external sites for Regulatory Inspections, and Regulatory Inspection Management.
  • Carmen Medina, MPH, Ph.D. (c), President, Precision Consultants, Inc., Coronado, CA, Former FDA Investigator

    Carmen uses over 30 years of FDA experience to support an array of U.S. and international clients in their preparations for successful Pre-Approval Inspections and FDA GMP inspections. Ms. Medina routinely guides clients in a variety of compliance matters, such as responding to Warning Letters, managing consent decrees, and designing commercialization strategies and litigation support. Carmen Medina was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations - QSR. She has conducted over 1200 GCP, GMP and QSR inspections resulting in an array of regulatory and criminal actions. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.
  • Mehron Mirian, Senior Quality Manager, Molecular Template

    Mehron Mirian has more than 18 years of experience in Quality and Engineering in the Medical Device, Pharmaceuticals, Biotechnology and Diagnostics industries. Mehron, who holds a BS in Biology, has worked for companies such as Cardinal Health, Bio-Rad, B.Braun, Avid, and Molecular Templates. Mehorn currently manages quality department in Molecular Templates as the Senior Quality Manager.
  • Lori Richter, Senior Consultant, ValSource

    Lori Richter is a Senior Consultant at ValSource. She holds a Bachelor of Science in Microbiology and over 20 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management (QRM), Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to becoming a consultant, she held previous roles such as a Site Risk Manager at a biologics facility, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of the global team responsible for the development and deployment of the QRM program across the Roche/Genentech Pharmaceutical Division. She has developed many QRM training modules and delivered training to both Health Authorities and industry teams. She was an author for PDA TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and is an Instructor for the PDA Quality Risk Management Certificate Program. She is the West Coast Chapter PDA President-elect and is pursuing her PhD at Technological University Dublin.
  • Aaron Roth, SME, QRM and CQV Program Development, CAI

    Aaron is a seasoned project manager and subject matter expert in the fields of Commissioning and Qualification and Quality Risk Management (QRM). He has led the implementation of QRM principles on several large projects to date, and delivered training to clients and to industry on this topic. Aaron has applied his engineering and leadership experience across the pharmaceutical industry, including commissioning and qualification, process validation, maintenance and reliability planning, and management, deviation investigations and root cause analysis, change management, quality system implementation, and GMP training.
  • Chinmoy Roy BSEE, MSCS, Data Integrity and CSV SME, ValGenesis

    Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Master’s degree in Computer Science.
  • Ravi Samavedam, General Manager, Azzur Group LLC.

    Ravi Samavedam as over 19 years of experience in the BioPharma industry in areas such as: Quality Systems Implementation, Technology Transfer, Process Validation, CMO oversight, Quality Auditing etc. Ravi has held various positions in departments including Technical Operations, Quality Engineering, Validation and Quality. He is a General Manager of Azzur Group, currently focusing on development and expansion of the Facility Solutions business operations, a unique and flexible solution for early phase manufacturing and related activities.
  • Tara Scherder, Partner, SynoloStats, LLC

    Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.
  • Ken Shitamoto, Senior Director, Gilead Sciences

    Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.
  • David Slotten, Senior Quality Systems Specialist, Quality Assurance and Regulatory Affairs, Promega

    David has worked in the regulated industry for over 15 years. Currently, David is working for Promega Life Sciences in Madison WI where his role as Quality System Specialist is to support work through the Change Control process. During his career, he has held quality positions within CRO’s, CMO’s, Medical Device and Pharma companies. His experiences include regulatory body audits, both external and internal audits, training, testing of products, and Change Control process development. He has a sincere appreciation of the sciences and enjoys working with others to improve the customer experience.
  • Emily S. D. Trubee, MS Stability Manager, ADARE Pharmaceuticals

    Ms. Trubee is a pharmaceutical professional with 14 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager, Research and Development at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.
  • David W. Vincent, Ph.D., CEO VTI Life Sciences

    Mr. Vincent has over 33 years’ experience in the health care industry specializing in the, biologic, biotechnology and biopharmaceutical industries and has over 25 years dedicated to the field of validation. Mr. Vincent has provided both project management and project execution for numerous clients national and international. He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
  • Sheba Zaman B.S. in Computer Science Head of Product Specialists and Training Services Novatek International

    Sheba Zaman has been serving in a technical role at Novatek International for over 17 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade to establish procedures, work instructions, validation scripts and training program related to their data management systems.

Sponsors

  • GOLD




  • A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
    Website: https://www.azzur.com/
  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com
  • PSC Biotech Corporation has three unique, active divisions within the parent company: our professional service division, PSC Biotech™; our software division, PSC Software™, and our contract manufacturing facility, BioTechnique. Each division is heavily rooted in regulatory expertise in order to meet the ever-changing needs of our clients around the globe.
    Website: https://www.biotech.com/
  • SILVER




  • Since 2010, the FDAzilla platform has been utilized by hundreds of clients, ranging from Fortune 500 companies in every FDA-regulated industry, to law firms, to insurance companies and banks, and to consultants. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe, and FDAzilla.com is viewed more than 1 million times per year.
    Website: https://fdazilla.com/
  • Novatek International’s mission is to produce regulatory compliant software solutions to the pharmaceutical, biotech and other health-care industries. Our goal is to improve patient safety by producing solutions that reduce the risks associated with pharmaceutical manufacturing and contribute to product quality.

    Website: https://ntint.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

Venue

Details

Start:
August 19
End:
August 21
Event Category:

Venue

Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(858) 488-0551
Website:
https://www.bahiahotel.com/

Pricing & Registration

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