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GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers Online Course – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers” training has been added to ResearchAndMarkets.com’s offering.


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.

Who Should Attend:

Key Topics Covered:

Lecture 1 – Introduction to GMP Auditing

Lecture 2 – API and Excipient Manufacturing Processes and Requirements

Lecture 3 – Auditing Planning and Preparation

Lecture 4 – Conducting the Audit

Lecture 5 – Audit Reporting and Documentation

Lecture 6 – Post-Audit Activities

Lecture 7 – Case Studies and Group Exercises

Speakers

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.”

For more information about this training visit https://www.researchandmarkets.com/r/ey4i7u

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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