• 3-Hour Virtual Seminar on FDA Inspection Readiness – Be Ready!

    3,000.007,000.00

    Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process.

    This 3-hour virtual seminar will walk-through every facet of the readiness inspection from your selection to be audited, through the process itself, to the handling the outcomes and everything in between. This seminar will identify those critical to compliance areas that must be properly addressed to ensure fully compliant and inspection ready operations

    Areas Covered in the Session :

    • The mechanics of the readiness process, auditing – who gets audited, frequency of audits, and the inspection process explained
    • Types of inspections and their implications
    • The heart of compliance – doing the right things right
    • Selecting your subject matter experts
    • Training your SME’s – what do they need to know and how do you train
    • Inspection preparedness – what to expect and how to prepare
    • The readiness inspection from the auditor’s perspective
    • Responding/interacting with the inspection team – inspection behavior – how to act – what to say and what not to say
    Who Should Attend:

    • Quality Assurance Departments
    • Quality Control Departments
    • Research and Development Departments
    • Regulatory Affairs Departments
    • Compliance Departments
    • Manufacturing Departments
    • Engineering Departments
    • Operations Departments
    • Production Departments
    • Validation Departments
    • Marketing Departments
    • Documentation Departments
    • Logistics & Wearhousing Departments
    • Virtually the entire spectrum of your organization
  • 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
  • Big Data in FDA-Regulated Industry – Best Practices for Systematic Use

    3,000.007,000.00

    In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity to learn about practical, actionable and sustainable approaches to maximally use the big data. In particular, the speaker will share how to most effectively identify and use the big data for practical application to your business in FDA-regulated industry (drugs, medical devices including IVDs, dietary supplements, cosmetics, etc.). This webinar will help you bring significant benefits including detailed strategies of how to use big data to your business practices and organization, tremendously helping you save enormous resources (time, energy and money) and beyond.

    In this 60-min presentation, the speaker will guide you through the details of how to identify and use big data for your maximum benefits applicable to FDA-regulated industry.

    At the end of this seminar, you will learn how to develop and implement best practices to systematically use big data using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive strategy in a Systematic, Integrated Manner.

    Areas Covered in the Session :

    • Applicable Laws, Regulations, Guidance, Rules, Standards
    • Definitions
    • Big Data Sources in Pharmaceuticals and Medical Devices
    • Power of Big Data
    • Data Mining
    • Drug Safety Data and Signals
    • Medical Device Safety Data
    • Solving Big Problems Using Big Data
    • Science Using Big Data
    • Big Data, Security and Privacy Matters
    • Big Data v. Drug Discovery
    • Revolution in FDA-Regulated Industry Using Big Data
    • Company’s Views on Big Data
    • Big Data: Current Trends
    • Big Data Driven Medicines
    • Big Data: Legal, Ethical and Policy Issues
    • Failure to Use Big Data
    • Inadequate Use of Big Data
    • Big Data Management
    • Big Data: Opportunities
    • Big Data: Challenges
    • Post-marketing surveillance
    • Systematic Use of Big Data: Best Practices
    • Speaker’s PASS-IT Suggestions/Recommendations
    • Speaker’s Experience and Actual Cases
    • Conclusion
    Who Should Attend:

    • Quality Departments
    • Regulatory Affairs Departments
    • Research and Development Departments
    • Manufacturing Departments
    • Engineering Departments
    • Operations Departments
    • Production Departments
    • Senior Management
    • Marketing Departments
    • Product Development Professionals
    • Clinical Affairs Professionals
    • Contractors and subcontractors
    • Consultants
    • Everyone interested in the topic
  • Compliance Trainings In House Training

    177,000.00

    In House Training by Ms. Balwinder Kaur

  • 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.
  • e-Compliance Conference Registration

    44,000.00

    Registration for CSV and IT Systems Validation Conference

  • e-Compliance Conference Sponsorship

    45,000.00

    Sponsorship Registration for CSV and IT Systems Validation Conference

  • 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.
  • FDA Rules for Pharmaceutical Analytical Method Validation

    5,000.00

    FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.

    Why You Should Attend:

    All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended..

    Areas Covered in the Session :

    • General Information
    • Specificity
    • Accuracy
    • Precision
    • Sensitivity
    • Linearity
    • Range
    • Robustness
    • Reproducibility

    Who Should Attend:

    • Analytical Method Development Supervisors
    • Analytical Method Validation Supervisors
    • Method Research Chemist
    • Analytical Chemists
    • QC and R&D Laboratory Supervisors
    • Regulatory Affairs Supervisors
  • 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