• Auditing Laboratory Data Systems

    3,000.007,000.00

    The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data.

    The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations.

    Areas Covered in the Session :

    • Categories of laboratory data system (GAMP)
    • Lifecycle management, archiving and backup
    • What counts as raw data?
    • Protecting the integrity of analytical data
    • General guidance on assigning user privileges
    • Operating system configuration.
    • Application configuration
    • Controls appropriate for chromatography data systems
    • Practices that aid compliance with data integrity requirements
    • Examples from recent FDA warning letters
    Who Should Attend:

    • Staff who are required to audit analytical operations who do not have a chemical QC background
    • Auditors who require updating on current regulatory expectations
    • QC staff who needs help in regulatory compliance
    • Staff who would like to understand the implications of data integrity for laboratory data systems
  • Data Governance for Computer Systems Regulated by FDA

    3,000.007,000.00

    Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost, complexity and risk associated with maintaining it, and ensure that all FDA compliance requirements are met.

    As decision making is a key area of interest in the regulated world, companies must be able to establish clear rules for managing source data used in critical regulatory decisions. Given the complexity of the data involved, and the compliance requirements mandated by FDA, organizations operating in this environment must have a formal system of governance.

    Organizations continue to be more data-driven, meaning effective data governance is essential to providing trusted, timely, high-quality data consistently to all users. Creating a data governance initiative can be a daunting task, leaving companies feeling overwhelmed, but there are best practices that can get you started quickly down the road to success by providing a framework with the necessary depth, breadth and flexibility to overcome common pitfalls.

    We will discuss the importance of establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations. A data governance framework is a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data. As data governed by FDA must adhere to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable, we will look at ways to leverage these in developing an overall data governance framework and program.

    Areas Covered in the Session :

    • Linking data governance activities and investments to corporate drivers, strategies and compliance
    • Establish data governance program objectives, decision-making organizational structures and assigned roles and responsibilities that fit within the organizational culture
    • Understand the role of data owners vs. data stewards
    • Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
    • Designing data governance processes that encompass people, processes and technology
    • Understand the policies and procedures necessary to support the data governance framework
    Who Should Attend:

    This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

    You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include::

    • Information Technology Analysts
    • Information Technology Developers and Testers
    • QC/QA Managers and Analysts
    • Analytical Chemists
    • Compliance and Audit Managers
    • Laboratory Managers
    • Automation Analysts
    • Computer System Validation Specialists
    • GMP Training Specialists
    • Business Stakeholders/Subject Matter Experts
    • Business System/Application Testers
    • This webinar will also benefit any consultants working in the life sciences industry who are
      involved in computer system implementation, validation and compliance.
  • FDA Compliance and Laboratory Computer System Validation

    3,000.007,000.00

    You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations.

    Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.

    There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

    Areas Covered in the Session :

    • Gain an understanding of laboratory system computer validation planning, execution and management concepts
    • Discuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costs
    • Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing
    • Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs
    • Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems
    • Understand the training that must be provided to business and IT staff involved in the validation process
    • Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality
    • Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality
    Who Will Benefit:

    This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

    You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Professionals who will benefit include:

    • Information Technology Analysts
    • Information Technology Developers and Testers
    • QC/QA Managers and Analysts
    • Analytical Chemists
    • Compliance and Audit Managers
    • Laboratory Managers
    • Automation Analysts
    • Computer System Validation Specialists
    • GMP Training Specialists
    • Business Stakeholders/Subject Matter Experts
    • Business System/Application Testers
    • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
  • Laboratory Accreditation – Getting there is Just the Beginning

    3,000.007,000.00

    Developing a Quality Management System (QMS) as a prerequisite for getting accredited is relatively easy. Maintaining the QMS to retain your accreditation status is the real challenge and a measure of the robustness your System.

    Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.

    – Why do you want to become accredited?

    – Where do you start?

    For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Getting there is relatively easy. Staying there is hard part.

    Areas Covered in the Session :

    • Defining a Quality Management System (QMS)
    • Management Components of a QMS
    • Technical Components of a QMS
    • Method Selection, Validation and Verification
    • Ensuring analytical competency
    • Ensuring analyst competency
    Who Should Attend:

    • Laboratory Management/Supervision
    • Laboratory Quality Development
    • Laboratory Quality Management
    • Laboratory Quality Control
    • Analytical Support
  • Sample Quality Control with Molecular Diagnostics

    3,000.007,000.00

    This webinar explains a variety of issues and how to address them. Common issues such as collection methods, sample inhibition and sample volume will be addressed. Also, each unique technology, from standard PCR, to DNA fluorescent assays, from next generation sequencing to newer technologies such as point of care and digital PCR, will have their various sample challenges addressed. This webinar will give you the tools you need to deal with your laboratories challenges.

    Why You Should Attend:

    Since the beginning of the PCR revolution in the 1980s, molecular diagnostics have proven to be a useful tool for the clinical laboratory. The ability to analyze a variety of samples for DNA and RNA content have proven to be useful for a large number of clinical conditions using a number of different technologies. However, each technology has its pitfalls with how to handle samples for optimal results. In addition, different technologies have different challenges as to what can inhibit optimal results and each technology has a unique solution to these pitfalls.

    Areas Covered in the Session :

    • Universal sample requirements for molecular diagnostics
    • Strategies to deal with common challenges
    • Challenges unique to PCR assays
    • Challenges unique to DNA fluorescent assays
    • Challenges unique to NGS assays
    • Challenges unique to newer molecular technologies
    Who Should Attend:

    • Quality Control Departments
    • Research and Development Departments
    • Validation Departments
    • Assay Development Professionals
    • Assay Validation Professionals
    • Clinical Diagnostics
  • Selecting and Managing Vendors in Clinical Research

    3,000.007,000.00

    This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.

    Why You Should Attend:

    Sponsors are responsible for vendor oversight, but how is this accomplished? Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach.

    This presentation will instruct the participant on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.

    Free Materials:

    • Reference documents
    • Rule documents or guidance
    • Checklist
    • Articles

    Areas Covered in the Session :

    The webinar will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.

    • What do the Regulations mean?
    • Vendor oversight – Where do you start?
    • Vendor management as a team approach
    • Defining requirements
    • Quality insight and input
    • Pre-Qualification of a vendor
    • Use of Tools and Processes
    • Managing vendor performance
    Who Will Benefit:

    • Quality Departments
    • Regulatory Affairs Departments
    • IT Departments
    • CEO’s, CTO’s, VP’s and Contract VP’s
    • Contract Personnel
    • GxP Consultants
  • Steam Sterilization Microbiology and Autoclave Performance Qualification

    3,000.007,000.00

    Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

    Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.

    Regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

    Common questions and hot topics in industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.

    Areas Covered in the Session :

    • Steam sterilization on a microbial level
    • IQ/OQ/PQ Requirements for Autoclave Validation
    • Regulatory and GMP requirements for steam sterilization
    • Autoclave Monitoring Tests
    • Process verification tools for use in an autoclave
    • Biological Indicators – How and When to Use
    • Common questions, problems and cGMPs
    • Verification vs. Revalidation
    Who Should Attend:

    • Quality Assurance Departments
    • Validation Departments
    • Sterility Assurance Departments
    • Validation Departments
  • Writing Validation Master Plans – Best Practices for Writing a Compliant Document

    3,000.007,000.00

    This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed.

    Various types and examples of VMPs will be given and discussed. Participants will learn how to effectively write a VMP most appropriate for their manufacturing organization. Why should you Attend: Attendees should register to learn the major components of a Validation Master Plans. They will learn how the VMP is different from Validation SOPs.

    Areas Covered in the Session :

    • What is a VMP and what is its intended use
    • How is a VMP different that validation SOPs
    • Components of a VMP
    • Regulatory requirements for a VMP
    • Team Writing a VMP
    • Examples of VMPs
    • Effective writing practices for an audit-ready document
    Who Should Attend:

    • Quality Assurance Departments
    • Quality Control Departments
    • Research and Development Departments
    • Regulatory Affairs Departments
    • Engineering Departments
    • Validation Departments
    • Documentation Departments
    • Consultants
    • Auditors