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


    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


    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


    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
  • Laboratory Accreditation – Getting there is Just the Beginning


    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
  • Selecting and Managing Vendors in Clinical Research


    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
  • Successful Change Control Management


    This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

    Areas Covered in the Session :

    1. Overview of Change Control Regulatory Requirements
      • What is Change Control?/Why Change Control?
      • Types of Changes Subject to Change Control
      • Like for Like
      • Specification changes
      • Facility Changes
      • Equipment Changes
      • Emergency Changes
    2. Change Control Proposal
      • Proper documentation
      • Elements to be included
    3. Change Assessment (Risk, Impact) and Approval to Execute
      • Impact to products
      • Impact to facility
      • Impact to Regulatory Filings
      • Change Control Board Development
      • Areas of Responsibilities for Board Members
      • Establishing Action Items
      • Establishing Deadlines
      • Final Implementation of Change
        • How to close out a change
    4. Effectiveness of the change
    5. Change Control Documentation
      • Hard copy systems
      • Electronic systems
    Who Should Attend:

    1. Quality Assurance Teams
    2. Quality Control Teams
    3. Manufacturing Teams
    4. Production Teams
    5. Regulatory Teams
    6. Management Teams
  • Writing Validation Master Plans – Best Practices for Writing a Compliant Document


    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