Instructor :
John E Lincoln

Webinar ID:
12558

In a rapidly evolving regulatory landscape, virtual site audits offer a flexible and powerful tool for maintaining FDA compliance.

This webinar will guide you through the essentials of conducting cGMP-compliance audits remotely to meet FDA requirements and inspect critical vendors, suppliers, and off-site facilities effectively.

Why Attend?

• • Stay Compliant with cGMP Standards: Annual site audits are essential to uphold cGMP standards across your quality management systems and ensure readiness for FDA evaluations, even when physical site visits aren’t feasible.
  • Master Virtual Audit Techniques: Learn how to incorporate virtual audits to bridge the compliance gap, particularly during disruptions like pandemics, travel restrictions, or other limitations.
  • Address FDA’s Evolving Expectations: Gain insights into the FDA’s increasing emphasis on continuous monitoring, frequent inspections, and proactive risk management in areas like clinical trials, product submissions, and process validation.
  • Proactively Manage Risks: Discover best practices for managing regulatory risks, especially for sites with previous 483 observations or compliance challenges. Virtual audits can help your QA/RA teams and senior management keep these high-stakes areas under close control.

Key Learning Outcomes:

• • Understand the FDA’s latest guidance on virtual site inspections
  • Discover how to conduct remote cGMP audits that meet FDA standards
  • Learn strategies to maintain a state of validation control across processes and respond proactively to FDA expectations

This 60-minute session will equip you with actionable strategies to incorporate virtual audits into your compliance approach, helping you remain FDA-compliant while navigating today’s remote-driven world.

Enroll Now!

In a rapidly evolving regulatory landscape, virtual site audits offer a flexible and powerful tool for maintaining FDA compliance.

This webinar will guide you through the essentials of conducting cGMP-compliance audits remotely to meet FDA requirements and inspect critical vendors, suppliers, and off-site facilities effectively.

Why Attend?

• • Stay Compliant with cGMP Standards: Annual site audits are essential to uphold cGMP standards across your quality management systems and ensure readiness for FDA evaluations, even when physical site visits aren’t feasible.
  • Master Virtual Audit Techniques: Learn how to incorporate virtual audits to bridge the compliance gap, particularly during disruptions like pandemics, travel restrictions, or other limitations.
  • Address FDA’s Evolving Expectations: Gain insights into the FDA’s increasing emphasis on continuous monitoring, frequent inspections, and proactive risk management in areas like clinical trials, product submissions, and process validation.
  • Proactively Manage Risks: Discover best practices for managing regulatory risks, especially for sites with previous 483 observations or compliance challenges. Virtual audits can help your QA/RA teams and senior management keep these high-stakes areas under close control.

Key Learning Outcomes:

• • Understand the FDA’s latest guidance on virtual site inspections
  • Discover how to conduct remote cGMP audits that meet FDA standards
  • Learn strategies to maintain a state of validation control across processes and respond proactively to FDA expectations

This 60-minute session will equip you with actionable strategies to incorporate virtual audits into your compliance approach, helping you remain FDA-compliant while navigating today’s remote-driven world.

Enroll Now!

As regulatory expectations and the need for flexibility in FDA compliance grow, virtual site audits have become an invaluable tool for companies in FDA-regulated industries.

This webinar is designed to equip you with the skills to effectively incorporate virtual cGMP audits into your compliance strategy, ensuring that your organization remains audit-ready and responsive to FDA requirements.

Top Reasons to Attend:

• • Enhance Your Compliance Strategy: Learn how virtual audits can help you meet FDA’s cGMP standards for drugs and devices when physical site visits are not possible. This approach supports continuity in your Internal Audit Program and critical vendor monitoring initiatives.
  • Stay Ahead of FDA Initiatives: Gain insights into the FDA’s latest initiatives and compliance areas, helping your QA/RA teams and senior management proactively address regulatory needs and mitigate risk.
  • Identify and Address Weak Spots: Discover strategies for remotely identifying compliance risks or gaps within your quality management system, with practical examples and tools to support remediation efforts.
  • Access Practical Tools and Templates: Walk away with implementation examples, suggested form templates, and data sources that make virtual audits more efficient and impactful.
  • Improve Career-Advancing Skills: Mastering virtual auditing skills positions you as a forward-thinking compliance professional, equipped to handle today’s complex regulatory landscape and demonstrate high-value expertise to your organization.

This session is a must-attend for professionals who want to strengthen their FDA compliance strategies, improve audit-readiness, and embrace innovative tools for managing compliance effectively in a remote-driven world.

Register today and take the first step toward mastering the future of compliance auditing!

Join Now!

As regulatory expectations and the need for flexibility in FDA compliance grow, virtual site audits have become an invaluable tool for companies in FDA-regulated industries.

This webinar is designed to equip you with the skills to effectively incorporate virtual cGMP audits into your compliance strategy, ensuring that your organization remains audit-ready and responsive to FDA requirements.

Top Reasons to Attend:

• • Enhance Your Compliance Strategy: Learn how virtual audits can help you meet FDA’s cGMP standards for drugs and devices when physical site visits are not possible. This approach supports continuity in your Internal Audit Program and critical vendor monitoring initiatives.
  • Stay Ahead of FDA Initiatives: Gain insights into the FDA’s latest initiatives and compliance areas, helping your QA/RA teams and senior management proactively address regulatory needs and mitigate risk.
  • Identify and Address Weak Spots: Discover strategies for remotely identifying compliance risks or gaps within your quality management system, with practical examples and tools to support remediation efforts.
  • Access Practical Tools and Templates: Walk away with implementation examples, suggested form templates, and data sources that make virtual audits more efficient and impactful.
  • Improve Career-Advancing Skills: Mastering virtual auditing skills positions you as a forward-thinking compliance professional, equipped to handle today’s complex regulatory landscape and demonstrate high-value expertise to your organization.

This session is a must-attend for professionals who want to strengthen their FDA compliance strategies, improve audit-readiness, and embrace innovative tools for managing compliance effectively in a remote-driven world.

Register today and take the first step toward mastering the future of compliance auditing!

Join Now!

• • Mandated Areas for Annual Reviews, Inspections, and Audits: Understand the critical regulatory areas requiring annual review to stay compliant with FDA standards.
  • Drug cGMPs (21 CFR 210/211): Learn about the specific cGMP requirements for pharmaceuticals and how to apply them in a virtual audit setting.
  • Device cGMPs (21 CFR 820): Gain insights into device-related cGMP regulations and their virtual audit implications.
  • Essentials of Virtual Audit Tools: Explore the tools and technology essential for conducting successful virtual audits and inspections.
  • Alternative Focus Areas for Device, Pharmaceutical, and Related cGMPs: Identify areas that can be prioritized in virtual audits, ensuring comprehensive coverage of regulatory needs.
  • Building and Training the Virtual Audit Team: Learn strategies for assembling an effective virtual audit team, including implementation techniques and training essentials.
  • Sample Virtual Audit Worksheets: Access practical templates and worksheets tailored for virtual audits to streamline the process.
  • Conducting the Virtual Audit: Master the steps for performing a virtual audit, from preparation to execution, ensuring a thorough review of compliance areas.
  • Disposition of Audit Findings: Understand how to evaluate and address findings from virtual audits to maintain cGMP standards.
  • Review, Follow-Up, and Monitoring for Effectiveness: Learn best practices for following up on audit findings, including monitoring improvements and ensuring long-term compliance effectiveness.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

• • Mandated Areas for Annual Reviews, Inspections, and Audits: Understand the critical regulatory areas requiring annual review to stay compliant with FDA standards.
  • Drug cGMPs (21 CFR 210/211): Learn about the specific cGMP requirements for pharmaceuticals and how to apply them in a virtual audit setting.
  • Device cGMPs (21 CFR 820): Gain insights into device-related cGMP regulations and their virtual audit implications.
  • Essentials of Virtual Audit Tools: Explore the tools and technology essential for conducting successful virtual audits and inspections.
  • Alternative Focus Areas for Device, Pharmaceutical, and Related cGMPs: Identify areas that can be prioritized in virtual audits, ensuring comprehensive coverage of regulatory needs.
  • Building and Training the Virtual Audit Team: Learn strategies for assembling an effective virtual audit team, including implementation techniques and training essentials.
  • Sample Virtual Audit Worksheets: Access practical templates and worksheets tailored for virtual audits to streamline the process.
  • Conducting the Virtual Audit: Master the steps for performing a virtual audit, from preparation to execution, ensuring a thorough review of compliance areas.
  • Disposition of Audit Findings: Understand how to evaluate and address findings from virtual audits to maintain cGMP standards.
  • Review, Follow-Up, and Monitoring for Effectiveness: Learn best practices for following up on audit findings, including monitoring improvements and ensuring long-term compliance effectiveness.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Everybody benefits from watching this. Even better when done as a group!

• • Quality and Compliance Managers Seeking Practical Tools for Remote Audits
  • Regulatory Affairs Leaders Focused on Meeting FDA’s Evolving Standards
  • Senior Management Committed to Strengthening Company-Wide FDA Compliance
  • Operations Managers Overseeing Critical Supplier and Vendor Compliance
  • Quality Assurance Teams Focused on Reducing Compliance Risks
  • Training Heads Building Comprehensive Compliance Learning Paths
  • HR Professionals Supporting Continuous Regulatory and Compliance Education
  • Supply Chain Managers Ensuring Supplier Adherence to FDA Standards
  • Clinical Operations Staff Needing Compliance Insights for cGMP Audits

Everybody benefits from watching this. Even better when done as a group!

• • Quality and Compliance Managers Seeking Practical Tools for Remote Audits
  • Regulatory Affairs Leaders Focused on Meeting FDA’s Evolving Standards
  • Senior Management Committed to Strengthening Company-Wide FDA Compliance
  • Operations Managers Overseeing Critical Supplier and Vendor Compliance
  • Quality Assurance Teams Focused on Reducing Compliance Risks
  • Training Heads Building Comprehensive Compliance Learning Paths
  • HR Professionals Supporting Continuous Regulatory and Compliance Education
  • Supply Chain Managers Ensuring Supplier Adherence to FDA Standards
  • Clinical Operations Staff Needing Compliance Insights for cGMP Audits