WHY SHOULD YOU ATTEND?
This webinar will be beneficial for anyone who may be involved in CAPA investigations. In particular, this course will be beneficial for Quality Teams, Quality Managers, Quality Specialists, Quality Associates - Manufacturing teams,AREA COVERED
1. Welcome and Introduction (15 minutes)• 1.2. Overview of the webinar objectives and agenda
• 1.3. Brief participant introduction (optional)
• 1.4. Technical tips for interacting with the webinar platform
2. Understanding CAPA (30 minutes)
• 2.1. Definition of Corrective and Preventive Actions
• 2.2. The importance of CAPA in quality management systems
• 2.3. Key differences between corrective and preventive actions
• 2.4. Overview of regulatory requirements and standards (e.g., ISO 9001, FDA)
Break (5 minutes)
3. The CAPA Process: Steps and Methodology (60 minutes)
• 3.1. Identifying the Problem
o Root cause analysis
o Tools for problem identification (e.g., Fishbone Diagram, 5 Whys)
• 3.2. Implementing Corrective Actions
o Developing action plans
o Assigning responsibilities and timelines
• 3.3. Preventive Actions
o Proactive measures to prevent recurrence
o Risk assessment and management
• 3.4. Verification and Validation
o Ensuring effectiveness of actions
o Monitoring and follow-up
Break (10 minutes)
4. CAPA Best Practices and Common Pitfalls (45 minutes)
• 4.1. Best practices for effective CAPA implementation
o Documentation and tracking
o Communication and training
• 4.2. Common challenges and pitfalls
o Avoiding overcomplication
o Ensuring consistency and accountability
• 4.3. Case studies and real-world examples
Interactive Q&A Session (30 minutes)
• Open floor for participant questions
• Addressing specific concerns or scenarios raised by participants
5. Tools and Resources for CAPA Management (30 minutes)
• 5.1. Overview of software tools for CAPA management
• 5.2. Templates and checklists
• 5.3. Further reading and resources
• 5.4. Recommendations for additional training
6. Wrap-Up and Closing Remarks (15 minutes)
• 6.1. Recap of key points and takeaways
• 6.2. Feedback survey and next steps
• 6.3. Contact information for follow-up questions
LEARNING OBJECTIVES
- The CAPA Process: Steps and Methodology
- Risk assessment and management
- Preventive Actions
- Verification and Validation
- CAPA Best Practices and Common Pitfalls
- Case studies and real-world examples
- Tools and Resources for CAPA Management
- Templates and checklists
WHO WILL BENEFIT?
- Quality Managers.
- Quality Specialists.
- Quality Associates.
- Quality Engineer.
• 1.2. Overview of the webinar objectives and agenda
• 1.3. Brief participant introduction (optional)
• 1.4. Technical tips for interacting with the webinar platform
2. Understanding CAPA (30 minutes)
• 2.1. Definition of Corrective and Preventive Actions
• 2.2. The importance of CAPA in quality management systems
• 2.3. Key differences between corrective and preventive actions
• 2.4. Overview of regulatory requirements and standards (e.g., ISO 9001, FDA)
Break (5 minutes)
3. The CAPA Process: Steps and Methodology (60 minutes)
• 3.1. Identifying the Problem
o Root cause analysis
o Tools for problem identification (e.g., Fishbone Diagram, 5 Whys)
• 3.2. Implementing Corrective Actions
o Developing action plans
o Assigning responsibilities and timelines
• 3.3. Preventive Actions
o Proactive measures to prevent recurrence
o Risk assessment and management
• 3.4. Verification and Validation
o Ensuring effectiveness of actions
o Monitoring and follow-up
Break (10 minutes)
4. CAPA Best Practices and Common Pitfalls (45 minutes)
• 4.1. Best practices for effective CAPA implementation
o Documentation and tracking
o Communication and training
• 4.2. Common challenges and pitfalls
o Avoiding overcomplication
o Ensuring consistency and accountability
• 4.3. Case studies and real-world examples
Interactive Q&A Session (30 minutes)
• Open floor for participant questions
• Addressing specific concerns or scenarios raised by participants
5. Tools and Resources for CAPA Management (30 minutes)
• 5.1. Overview of software tools for CAPA management
• 5.2. Templates and checklists
• 5.3. Further reading and resources
• 5.4. Recommendations for additional training
6. Wrap-Up and Closing Remarks (15 minutes)
• 6.1. Recap of key points and takeaways
• 6.2. Feedback survey and next steps
• 6.3. Contact information for follow-up questions
- The CAPA Process: Steps and Methodology
- Risk assessment and management
- Preventive Actions
- Verification and Validation
- CAPA Best Practices and Common Pitfalls
- Case studies and real-world examples
- Tools and Resources for CAPA Management
- Templates and checklists
- Quality Managers.
- Quality Specialists.
- Quality Associates.
- Quality Engineer.
Speaker Profile
Ms. Marie Dorat, is a hands on Regulatory/Quality Professional with 23 years experience in the Medical Device, Biopharmaceutical/Pharmaceutical industries in various senior positions. She has a high level of expertise in the regulatory/quality arenas, with an astute knowledge of GCP, cGMP QMS Development, validation, CAPA, NCMR, Change Control, and Training. Ms. Dorat is also a certified Lead Auditor for ISO/IVDR/MDSAP and has published articles for compliance magazines related to Clinical Site Inspections FDA vs. EU; Developing a compliant Quality System to name two.She has facilitated e-QMS enterprise development, software validations, worked in a Consent Decree environment and supported remediation …
Upcoming Webinars
From Challenges to Compliance: Understanding Dietary Supple…
How To Conduct An Internal Harassment And Bullying Investig…
Improving Employee Engagement & Retention Through Stay Inte…
Using Behavior Based Interviewing for Finding the Best Matc…
Leadership: Strategic Planning and Decision Making
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Documenting Employee Behaviour, Performa…
De-Stressing Your Leadership for Greater Impact
Emotional Intelligence: Mastering the Emotions of Great Lea…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
How to Conduct Exit Interviews - Implementing and Enhancing…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Finance & Accounting 101 Simplified
Understanding How To Write A Compliant CAPAs
Mastering the Candidate Experience in Talent Acquisition.
4-Hour Virtual Seminar on Transformational Leadership - The…
Uplifting the Credibility of HR: How to Build the Credibili…
Treasury Risk Management, Funding, Liquidity, Interest Rate…
Courts No Longer Have to Give Deference to Agency’s “Expert…
21 CFR Part 820 - Quality System Regulation - Applying Prin…
Building Fair Chance Hiring Policies in 2024
HIPAA Bootcamp for Health Care Providers, Professionals, an…
Building GMP Excellence: A Guide to Implementing Compliant …
FDA Technology Modernization Action Plan (TMAP) and Impact …
Weathering the Storm: Navigating Resource Constrained Waters
How to Survive an Emotionally Toxic Workplace
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Excel Power Skills: Master Functions, Formulas, and Macros …
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Understanding the Artificial Intelligence Landscape
Employee Handbook Requirements for 2024. Includes Updated F…
Essential Job Functions According to the American with Disa…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
FDA Audit Best Practices - Do's and Don'ts
Engineering Change Management (ECM)
Batch Record Review and Product Release
Workplace Investigations 101: How to Conduct your Investiga…