Contract Manufacturing: Responsibility and Accountability
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Speaker : FELICIA KERSEY ANGUS
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When : Tuesday, March 11, 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.
This course dives deep into the critical aspects of overseeing contract manufacturing to guarantee quality, compliance, and accountability. Participants will explore strategies for effective oversight, risk mitigation, and best practices to ensure reliable and high-quality production outputs from third-party manufacturers. The curriculum covers essential legal and regulatory frameworks for managing contract manufacturing, offering practical insights through case studies and interactive sessions. It caters to both newcomers to the field and those looking to enhance their existing knowledge, providing the tools and techniques needed to manage contract manufacturing partnerships with confidence and precision.
Key topics include an introduction to contract manufacturing, establishing and maintaining quality standards, and developing robust risk management and mitigation strategies. Participants will learn best practices in supplier audits and inspections, as well as how to ensure compliance with legal and regulatory requirements. Practical case studies and problem-solving workshops will offer hands-on experience, while discussions on innovative solutions for common challenges will enrich the learning experience. By the end of the course, attendees will have mastered the principles of managing contract manufacturing relationships, developed effective risk management strategies, ensured compliance with necessary regulations, implemented best practices for supplier accountability, and gained valuable insights through real-world examples.
Areas Covered
- Key elements of contract manufacturing agreements
- Roles and responsibilities of parties involved
- Best practices for managing contracts
Who Should Attend
This course is designed for quality managers, supply chain professionals, regulatory affairs specialists, and anyone involved in overseeing contract manufacturing processes.
Why Should You Attend
Attending a seminar on managing and ensuring accountability in contract manufacturing can be incredibly beneficial:
- Enhanced Oversight: Learn strategies to better oversee third-party manufacturers, ensuring they meet your quality and compliance standards
- Risk Mitigation: Gain insights into identifying and mitigating risks associated with outsourcing production, protecting your brand's reputation
- Best Practices: Discover industry best practices for maintaining accountability, from auditing processes to contract stipulations
- Legal Compliance: Understand the legal aspects of contract manufacturing to avoid potential pitfalls and ensure regulatory compliance
- Innovation Exchange: Meet industry experts and peers, exchanging innovative ideas and solutions to common challenges
- Problem Solving: Workshops and case studies can provide practical solutions to real-world problems you might face in contract manufacturing
Topic Background
Understanding the roles and responsibilities in contract manufacturing agreements.
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$160.00
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