Instructor :
Multiple Speakers

Webinar ID:
11926

Included 3 Courses in the Regulatory Compliance Essentials Pack:

• • Mastering the Essentials of GMPs: Your Guide to FDA Compliance
    • • Duration: 4 Hours | Scheduled Date: Oct 03, 2024 | Time: 10:00 AM – 2:00 PM EST

• • Risk-Based CSV and 21 CFR Part 11: Streamlining FDA Compliance and Data Integrity
    • • Duration: 4 Hours | Scheduled Date: Oct 04, 2024 | Time: 10:00 AM – 2:00 PM EST

• • FDA Audit Mastery: Proven Strategies for Effective Preparation and Execution
    • • Duration: 6 Hours | Scheduled Date: Oct 09, 2024 | Time: 9:00 AM – 3:00 PM EST

Key Benefits of the Pack:

1. 1. Flexible Participation: You can nominate different participants for each course; gift them to various team members for broader learning.
   2. Extended Access: 12-month unlimited access to the recordings—6 months extra than the standard access period.
   3. Presentation Handouts: Receive a PDF copy of each course’s presentation for future reference.
   4. Completion Certificate: Request a soft copy of the certificate of completion for professional development.
   5. Interactive Q&A Sessions: Engage with the presenter through Q&A sessions to get your pressing questions answered via chat, email, or live.

Pack Description:

This 3-course pack is your ultimate guide to mastering FDA compliance with a focus on GMP fundamentals, risk-based approaches to CSV, and effective FDA audit preparations.

As year-end approaches, this is the perfect time to sharpen your skills, ensure your systems are audit-ready, and stay ahead of regulatory changes. Gain essential insights into the latest compliance trends and learn practical strategies to….

Included 3 Courses in the Regulatory Compliance Essentials Pack:

• • Mastering the Essentials of GMPs: Your Guide to FDA Compliance
    • • Duration: 4 Hours | Scheduled Date: Oct 03, 2024 | Time: 10:00 AM – 2:00 PM EST

• • Risk-Based CSV and 21 CFR Part 11: Streamlining FDA Compliance and Data Integrity
    • • Duration: 4 Hours | Scheduled Date: Oct 04, 2024 | Time: 10:00 AM – 2:00 PM EST

• • FDA Audit Mastery: Proven Strategies for Effective Preparation and Execution
    • • Duration: 6 Hours | Scheduled Date: Oct 09, 2024 | Time: 9:00 AM – 3:00 PM EST

Key Benefits of the Pack:

1. 1. Flexible Participation: You can nominate different participants for each course; gift them to various team members for broader learning.
   2. Extended Access: 12-month unlimited access to the recordings—6 months extra than the standard access period.
   3. Presentation Handouts: Receive a PDF copy of each course’s presentation for future reference.
   4. Completion Certificate: Request a soft copy of the certificate of completion for professional development.
   5. Interactive Q&A Sessions: Engage with the presenter through Q&A sessions to get your pressing questions answered via chat, email, or live.

Pack Description:

This 3-course pack is your ultimate guide to mastering FDA compliance with a focus on GMP fundamentals, risk-based approaches to CSV, and effective FDA audit preparations.

As year-end approaches, this is the perfect time to sharpen your skills, ensure your systems are audit-ready, and stay ahead of regulatory changes. Gain essential insights into the latest compliance trends and learn practical strategies to safeguard your operations, reduce compliance costs, and enhance your organization’s quality standards.

” Webinar 1: Mastering the Essentials of GMPs: Your Guide to FDA Compliance Rationale (Oct 03, 2024, THU)”

Description:

• • This webinar covers the core principles of Good Manufacturing Practices (GMPs)—a critical foundation for any FDA-regulated environment.
  • As regulations evolve, this course ensures your team stays compliant and up-to-date on the latest GMP requirements, helping to mitigate risks and maintain high-quality standards.
  • Ideal for professionals looking to solidify their understanding of GMPs before the end of the year, setting a strong compliance base.

” Webinar 2: Risk-Based CSV and 21 CFR Part 11: Streamlining FDA Compliance and Data Integrity (Oct 04, 2024, FRI)”

Description:

• • This session dives into the risk-based approach to Computer System Validation (CSV) and 21 CFR Part 11 compliance, crucial for organizations implementing computerized systems.
  • It addresses how to minimize compliance burdens while meeting regulatory expectations.
  • With a focus on risk management and data integrity, it’s perfectly timed for those preparing for new system implementations or seeking to streamline their existing compliance processes before year-end.

” Webinar 3: FDA Audit Mastery: Proven Strategies for Effective Preparation and Execution (Oct 09, 2024, WED)”

Description:

• • Get comprehensive guidance on navigating FDA audits with confidence. This in-depth seminar teaches proven strategies for audit preparation, execution, and follow-up, ensuring your operations withstand regulatory scrutiny.
  • Timely as year-end audits and inspections loom, this course equips you with actionable insights to bolster your compliance posture, reduce audit risks, and enhance your audit readiness with best practices directly from industry experts.

Join Now!

As we approach year-end, regulatory audits, compliance updates, and quality checks are at the forefront of every FDA-regulated business.

This 3-course pack is tailored for professionals who need to ensure their processes, systems, and teams are audit-ready and compliant. Here’s why this pack is essential:

• • Address Critical Compliance Gaps: Ensure your organization meets the latest GMP standards, adheres to CSV requirements, and is fully prepared for FDA audits.
  • Minimize Compliance Risks: Learn practical, risk-based approaches to compliance that reduce operational burdens and help you avoid costly errors.
  • Prepare for Year-End Audits: Equip yourself with the latest insights to streamline audit preparations and reduce stress as the audit season approaches.

Why Each Course is a Crucial Component

• • Fundamentals of GMPs: As compliance scrutiny intensifies, this course provides the essential GMP knowledge needed to maintain high-quality standards. Perfect for QA/QC professionals and manufacturing managers preparing for upcoming inspections.
  • Risk-Based Approach to CSV, 21 CFR Part 11: This course tackles the complexities of computer system validation and data integrity, addressing key pain points for validation engineers, IT professionals, and compliance officers managing new or existing systems.
  • Successfully Preparing for FDA Audits: With audit season right around the corner, this course delivers critical audit readiness strategies to ensure you can conduct a successful FDA audit. Ideal for regulatory affairs specialists and compliance teams seeking to reduce audit findings and improve compliance.

Register now to gain practical, actionable insights and stay ahead in the ever-evolving world of FDA compliance!

Enroll Now!

As we approach year-end, regulatory audits, compliance updates, and quality checks are at the forefront of every FDA-regulated business.

This 3-course pack is tailored for professionals who need to ensure their processes, systems, and teams are audit-ready and compliant. Here’s why this pack is essential:

• • Address Critical Compliance Gaps: Ensure your organization meets the latest GMP standards, adheres to CSV requirements, and is fully prepared for FDA audits.
  • Minimize Compliance Risks: Learn practical, risk-based approaches to compliance that reduce operational burdens and help you avoid costly errors.
  • Prepare for Year-End Audits: Equip yourself with the latest insights to streamline audit preparations and reduce stress as the audit season approaches.

Why Each Course is a Crucial Component

• • Fundamentals of GMPs: As compliance scrutiny intensifies, this course provides the essential GMP knowledge needed to maintain high-quality standards. Perfect for QA/QC professionals and manufacturing managers preparing for upcoming inspections.
  • Risk-Based Approach to CSV, 21 CFR Part 11: This course tackles the complexities of computer system validation and data integrity, addressing key pain points for validation engineers, IT professionals, and compliance officers managing new or existing systems.
  • Successfully Preparing for FDA Audits: With audit season right around the corner, this course delivers critical audit readiness strategies to ensure you can conduct a successful FDA audit. Ideal for regulatory affairs specialists and compliance teams seeking to reduce audit findings and improve compliance.

Register now to gain practical, actionable insights and stay ahead in the ever-evolving world of FDA compliance!

Enroll Now!

WEBINAR 1: Mastering the Essentials of GMPs: Your Guide to FDA Compliance Rationale

• Quality Management: The Backbone of All Production
• Personnel: Ensuring Every Hand in the Process Is Skilled
• Premises and Equipment: Building the Foundation of Production
• Materials Management: Overseeing Resources Meticulously
• Documentation: Keeping Every Detail in Check
• Production: The Heart of GMP
• Production and In-Process Controls: Monitoring for Flawless Results
• Quality Assurance: Double-Checking for Perfection
• Validation: Confirming Processes’ Effectiveness
• Change Control: Managing Modifications Seamlessly
• Laboratory Controls: Validating Each Step Scientifically
• Supplier Controls: Ensuring Every Contributor Meets the Standard
• Packaging and Labeling: The Final Touch Before Products Meet Customers
• Storage and Distribution: Ensuring Safe Delivery
• Rejection and Re-Use of Material: Waste Not, Want Not
• Complaints and Recalls: Addressing Concerns Proactively

WEBINAR 2: Risk-Based CSV and 21 CFR Part 11: Streamlining FDA Compliance and Data Integrity

• 21 CFR Part 11 Compliance: Understand the Essential Compliance Requirements.
• Regulatory Updates and Future Trends: Discover Recent Regulatory Changes and Future Trends Affecting CSV.
• Data Governance and Integrity: Unpack the FDA’s 2018 Guidance on These Key Areas.
• Industry Compliance Best Practices: Explore Top Standards in System Validation.
• Streamlining FDA Compliance: Learn Cost-Effective and Simplified Compliance Strategies.
• Risk Management Frameworks: Explore Practical Risk Frameworks for CSV, Encouraging a Proactive Approach.
• SDLC Methodology: Learn How It Bolsters Computer System Validation.
• SDLC Best Practices: Discuss Top Industry Practices for the SDLC Methodology.
• Effective Documentation: Master the Art of Documenting and Maintaining Validated Systems.
• Vendor Audit Essentials: Learn How to Thoroughly Audit Vendors in Your Supply Chain.
• Validation Trends: Stay Informed About Evolving Best Practices in Validation.
• Case Studies and Real-World Examples: Examine Real-World CSV Applications, Highlighting Key Successes and Lessons.

WEBINAR 3: FDA Audit Mastery: Proven Strategies for Effective Preparation and Execution

I. Understanding The Inspection Framework

• FDA Inspection Operations – How They Do It
  • Risk-Based Approaches For Prioritizing Sites For GMP Inspection
  • ICH Q9/Q10 Guidelines
• Types Of Inspections
  • Pre-Approval
  • Post-Approval
  • Product Surveillance
  • For Cause
• What Gets Inspected?
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
• Who Gets Inspected?
• The Systems-Based Approach
• Inspectional Trends
• Enforcement
• Inspection Considerations
  • Medical Devices
  • Drug Production
  • Clinical Trials

II. Preparation And Conduct Of Inspection

• Preparation For The Inspection
  • General Preparation Strategies
    • The 3I Approach: Implement, Inspect, Incorporate
    • Gap Analysis And Root Cause Determination
  • Specific Preparations For GCP, GLP, And cGMP
• Understanding The FDA Investigator
  • Inside The Mind Of An FDA Investigator
  • General FDA Inspection Protocol
• Conduct During The Inspection
  • Importance Of Truthfulness, Knowledgeability, And Confidence
  • Techniques FDA Uses To Elicit Information
  • The Role And Importance Of Documentation
  • Effective Communication Skills During Inspection
  • Handling Adverse Findings During The Inspection
• Inspection Do’s And Don’ts
  • Encouraged And Discouraged Behaviors
  • Critical Phrases Never To Say
  • How To Argue And Challenge Findings Appropriately

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.

WEBINAR 1: Mastering the Essentials of GMPs: Your Guide to FDA Compliance Rationale

• Quality Management: The Backbone of All Production
• Personnel: Ensuring Every Hand in the Process Is Skilled
• Premises and Equipment: Building the Foundation of Production
• Materials Management: Overseeing Resources Meticulously
• Documentation: Keeping Every Detail in Check
• Production: The Heart of GMP
• Production and In-Process Controls: Monitoring for Flawless Results
• Quality Assurance: Double-Checking for Perfection
• Validation: Confirming Processes’ Effectiveness
• Change Control: Managing Modifications Seamlessly
• Laboratory Controls: Validating Each Step Scientifically
• Supplier Controls: Ensuring Every Contributor Meets the Standard
• Packaging and Labeling: The Final Touch Before Products Meet Customers
• Storage and Distribution: Ensuring Safe Delivery
• Rejection and Re-Use of Material: Waste Not, Want Not
• Complaints and Recalls: Addressing Concerns Proactively

WEBINAR 2: Risk-Based CSV and 21 CFR Part 11: Streamlining FDA Compliance and Data Integrity

• 21 CFR Part 11 Compliance: Understand the Essential Compliance Requirements.
• Regulatory Updates and Future Trends: Discover Recent Regulatory Changes and Future Trends Affecting CSV.
• Data Governance and Integrity: Unpack the FDA’s 2018 Guidance on These Key Areas.
• Industry Compliance Best Practices: Explore Top Standards in System Validation.
• Streamlining FDA Compliance: Learn Cost-Effective and Simplified Compliance Strategies.
• Risk Management Frameworks: Explore Practical Risk Frameworks for CSV, Encouraging a Proactive Approach.
• SDLC Methodology: Learn How It Bolsters Computer System Validation.
• SDLC Best Practices: Discuss Top Industry Practices for the SDLC Methodology.
• Effective Documentation: Master the Art of Documenting and Maintaining Validated Systems.
• Vendor Audit Essentials: Learn How to Thoroughly Audit Vendors in Your Supply Chain.
• Validation Trends: Stay Informed About Evolving Best Practices in Validation.
• Case Studies and Real-World Examples: Examine Real-World CSV Applications, Highlighting Key Successes and Lessons.

WEBINAR 3: FDA Audit Mastery: Proven Strategies for Effective Preparation and Execution

I. Understanding The Inspection Framework

• FDA Inspection Operations – How They Do It
  • Risk-Based Approaches For Prioritizing Sites For GMP Inspection
  • ICH Q9/Q10 Guidelines
• Types Of Inspections
  • Pre-Approval
  • Post-Approval
  • Product Surveillance
  • For Cause
• What Gets Inspected?
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
• Who Gets Inspected?
• The Systems-Based Approach
• Inspectional Trends
• Enforcement
• Inspection Considerations
  • Medical Devices
  • Drug Production
  • Clinical Trials

II. Preparation And Conduct Of Inspection

• Preparation For The Inspection
  • General Preparation Strategies
    • The 3I Approach: Implement, Inspect, Incorporate
    • Gap Analysis And Root Cause Determination
  • Specific Preparations For GCP, GLP, And cGMP
• Understanding The FDA Investigator
  • Inside The Mind Of An FDA Investigator
  • General FDA Inspection Protocol
• Conduct During The Inspection
  • Importance Of Truthfulness, Knowledgeability, And Confidence
  • Techniques FDA Uses To Elicit Information
  • The Role And Importance Of Documentation
  • Effective Communication Skills During Inspection
  • Handling Adverse Findings During The Inspection
• Inspection Do’s And Don’ts
  • Encouraged And Discouraged Behaviors
  • Critical Phrases Never To Say
  • How To Argue And Challenge Findings Appropriately

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 Assurance Managers: Facing challenges in maintaining GMP compliance and quality standards.
• Regulatory Affairs Specialists: Needing strategies for successful FDA audit preparations and execution.
• Validation Engineers: Struggling with complex CSV and 21 CFR Part 11 requirements.
• Compliance Officers: Looking to minimize compliance risks and streamline audit readiness.
• Manufacturing Managers: Addressing GMP implementation challenges and audit preparations in production areas.
• IT and System Administrators: Managing compliance for computerized systems and data integrity issues.
• Auditors and Inspectors: Seeking updated knowledge on GMPs and effective audit management techniques.

Everybody Benefits from Watching This. Even Better When Done as a Group!

• Quality Assurance Managers: Facing challenges in maintaining GMP compliance and quality standards.
• Regulatory Affairs Specialists: Needing strategies for successful FDA audit preparations and execution.
• Validation Engineers: Struggling with complex CSV and 21 CFR Part 11 requirements.
• Compliance Officers: Looking to minimize compliance risks and streamline audit readiness.
• Manufacturing Managers: Addressing GMP implementation challenges and audit preparations in production areas.
• IT and System Administrators: Managing compliance for computerized systems and data integrity issues.
• Auditors and Inspectors: Seeking updated knowledge on GMPs and effective audit management techniques.