GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers

This comprehensive course provides attendees with the essential knowledge and skills to conduct effective GMP audits of pharmaceutical API and excipient suppliers. Participants will gain a thorough understanding of GMP principles, the specific requirements for API and excipient manufacturing, auditing techniques, and post-audit activities. Through interactive sessions, case studies, and practical exercises, participants will learn how to plan and execute audits, classify observations, and report findings accurately. The course will cover the nuances of API and excipient GMP requirements, enabling participants to assess supplier compliance effectively. Furthermore, attendees will learn about post-audit activities such as evaluating corrective actions, conducting follow-up audits, and managing supplier relationships. This course is ideal for professionals involved in regulatory affairs, quality assurance, auditing, and supplier management, working in the pharmaceutical industry. By attending this course, participants will enhance their auditing skills, contribute to product quality and patient safety, and ensure regulatory compliance with respect to API and excipient suppliers.

WHY YOU SHOULD ATTEND:

Without proper GMP auditing of API and excipient suppliers, your organization is at risk of compromised product quality, regulatory non-compliance, and potential harm to patients. Stay ahead of the game by attending our comprehensive training, where you'll gain the essential skills and knowledge to effectively assess supplier compliance, identify critical issues, and ensure the safety and efficacy of your pharmaceutical products. Don't let inadequate auditing practices leave your organization vulnerable to costly recalls, damaged reputation, and regulatory penalties. Join us and empower your team with the expertise needed to navigate the complexities of API and excipient manufacturing, mitigate risks, and maintain a robust supply chain. Invest in this training today and safeguard your organization's success, customer trust, and most importantly, the well-being of patients relying on your products. The consequences of neglecting GMP auditing can be severe, so don't wait until it's too late. Take action now and secure the future of your pharmaceutical operations with our industry leading GMP Auditing course.

SEMINAR AGENDA:

Lecture 1 – Introduction to GMP Auditing

• Overview of GMP principles and their significance in the pharmaceutical industry
• Introduction to GMP auditing and its role in supplier qualification and quality assurance.
• Regulatory requirements and expectations for GMP auditing of API and excipient suppliers

Lecture 2 – API and Excipient Manufacturing Processes and Requirements

• Understanding the differences between API and excipient manufacturing processes.
• Specific GMP requirements for API manufacturing
• Specific GMP requirements for excipient manufacturing
• Common challenges and compliance issues in API and excipient manufacturing

Lecture 3 – Auditing Planning and Preparation

• Defining the scope and objectives of supplier audits.
• Developing audit plans, checklists, and protocols.
• Conducting risk assessments and prioritizing audit activities.
• Preparing necessary documentation and conducting pre-audit activities

Lecture 4 – Conducting the Audit

• Opening meetings and establishing rapport with suppliers.
• Facility tours and observation of manufacturing processes
• Document reviews and data analysis
• Conducting interviews with key personnel.
• Techniques for effective communication and maintaining objectivity during the audit

Lecture 5 – Audit Reporting and Documentation

• Structure and content of audit reports
• Classifying and documenting observations and findings
• Evaluating non-conformances and identifying opportunities for improvement.
• Reporting audit findings to stakeholders

Lecture 6 – Post-Audit Activities

• Corrective and preventive actions (CAPA) management
• Follow-up audits and assessing the implementation of corrective actions.
• Supplier relationship management and communication strategies
• Continuous improvement and lessons learned from audits

Lecture 7 – Case Studies and Group Exercises

• Analyzing real-life scenarios and case studies related to API and excipient supplier audits

WHO SHOULD ATTEND:

• Quality Assurance (QA) Departments
• Quality Control (QC) Departments
• Regulatory Affairs Departments
• Supplier Management Professionals
• Auditing Professionals
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Compliance Professionals
• Everyone responsible for ensuring GMP compliance and product quality

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 28 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in FDA-compliant new product development and to market issues, quality assurance, regulatory affairs, QMS problem remediation and FDA responses, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters in peer reviewed publications (5 chapters in RAPS textbook on V&V) conducted workshops and webinars worldwide on virtually all cGMP issues. John is a graduate of UCLA.