Is a Certificate of Analysis (CoA) Enough?
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Speaker : FELICIA KERSEY ANGUS
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When : Tuesday, February 25, 2025
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Time : 01 : 00 PM EST
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Felicia Angus is an accomplished pharmaceutical industry leading expert in Quality Assurance and Quality Control. With extensive experience in executing and monitoring compliance with regulatory requirements from agencies such as the FDA, EMA, DEA, Canadian, Japanese, Swedish authorities, ICH, and 21 CFR 820, Felicia brings a wealth of knowledge and expertise to her role. She has a deep understanding of the regulatory requirements necessary to meet standards for cGMPs, cGLPs, FDA regulations, and guidance documents.
Felicia has a strong background in hosting FDA inspections and providing recommendations for corrective actions to companies that have received Consent Decrees and Warning Letters. Her experience spans various compliance-related positions at notable companies including Novartis Animal Health, Biogen Idec, GlaxoSmithKline, Abraxis Bioscience, Danchem Technologies, Wyeth, and Pfizer.
Current Educa
- Master of Science in Management and Leadership (in progress) from Western Governors University
Previous Education:
- Bachelor of Science in Chemistry from North Carolina Agricultural & Technical State University
Experience:
- Extensive experience in Quality Assurance and Quality Control
- Expertise in regulatory compliance with FDA, EMA, DEA, Canadian, Japanese, Swedish, ICH, and 21 CFR 820 requirements
- In-depth knowledge of cGMPs, cGLPs, FDA regulations, and guidance documents
- Proven track record in hosting FDA inspections and advising on corrective actions for Consent Decrees and Warning Letters
- Held compliance-related positions at:
- Novartis Animal Health
- Biogen Idec
- GlaxoSmithKline
-Abraxis Bioscience
- Danchem Technologies
- Wyeth
- Pfizer
Current Residence:
Greensboro, North Carolina
Felicia’s
extensive background and ongoing commitment to education make her a
valuable resource for anyone looking to deepen their understanding of
quality assurance and regulatory compliance in the pharmaceutical
industry.
The topic of the role of Certificates of Analysis (CoAs) in quality management and supplementary practices encompasses several key areas:
Role of CoAs in Quality Management
- Verification of Product Quality: CoAs provide detailed information about the quality and purity of products, ensuring that they meet specified standards
- Traceability: They include batch numbers and testing dates, which help in tracing any issues back to their source
- Regulatory Compliance: CoAs are essential for meeting regulatory requirements and passing inspections by authorities like the FDA
- Supplier Oversight: They are used by materials suppliers to communicate the quality of their products to customers, ensuring that each lot or unit is manufactured, tested, and qualified for use
- Supplementary Practices in Quality Assurance
- Quality Control (QC) Methods: Implementing robust QC methods to ensure products meet quality standards
- Quality Assurance (QA) Processes: Systematic activities to provide confidence that products fulfill quality requirements3.
- Risk Assessment: Conducting comprehensive risk assessments to identify and mitigate potential quality issues
- Supplier Qualification: Establishing strict procedures for supplier qualification to ensure reliable and high-quality materials
- Continuous Improvement: Ongoing efforts to enhance product quality, service quality, and process efficiency
- These practices work together to create a comprehensive quality management system that ensures products consistently meet or exceed customer expectations.
Areas Covered
- Definition and purpose of CoAs
- Limitations of relying solely on CoAs
- Additional quality assurance practices
Who Should Attend
Quality Assurance Professionals, Regulatory Affairs Specialists, Production Managers
Why Should You Attend
Webinar to Understand the limitations of CoAs and explore additional quality assurance measures.Copilot
Attending a seminar on the limitations of Certificates of Analysis (CoAs) and exploring additional quality assurance measures can be incredibly beneficial for several reasons:
- Deepen Understanding: You'll gain a comprehensive understanding of the limitations of CoAs, which are often used to verify the quality and purity of products. Knowing these limitations can help you better interpret and utilize CoAs in your work.
- Explore Alternatives: The seminar will introduce you to additional quality assurance measures that can complement or even replace CoAs, providing a more robust quality control system
- Stay Updated: Quality assurance is a rapidly evolving field. Attending seminars helps you stay current with the latest trends, technologies, and best practices
- Networking Opportunities: These events are great for meeting other professionals in the field, sharing experiences, and learning from each other
- Practical Insights: Often, seminars include case studies and real-world examples, giving you practical insights that you can apply directly to your work
- Enhance Credibility: By staying informed and implementing advanced quality assurance measures, you can enhance the credibility and reputation of your organization
Topic Background
Evaluating the sufficiency of CoAs in ensuring product quality and compliance.
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$160.00
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