Field-Tested Techniques for Enhanced Audit Preparedness in Pharma Industry Webinar (On-Demand) - ResearchAndMarkets.com

The "Internal and External / Supplier Audits Essentials" has been added to ResearchAndMarkets.com's offering.

In response to the ever-increasing rigor of U.S. FDA cGMP compliance inspections, a new seminar has been announced that will equip pharmaceutical companies with critical insights and techniques for conducting internal and supplier/vendor audits. The program promises to impart a structured approach, emulating the intensity and scrutiny of actual FDA inspections, to help companies stay ahead in the demanding regulatory environment.

Expectations of External Inspections

Regulatory oversight is evolving, with not just domestic, but also global companies experiencing heightened scrutiny from U.S. FDA enforcement. This seminar is designed to dissect the anatomy of a 'typical' FDA inspection and apply these fundamentals to internal and supplier audits. The strategic approach detailed within the course will assist companies in anticipating key areas of focus during actual regulatory audits, ensuring thorough preparedness.

Internal and Supplier/Vendor Audit Framework

Participants will receive test scripts and a model for constructing effective audits within their own companies, as well as guidance for evaluating supplier compliance. The content presented will cover the initial notification process, setting the audit agenda, and daily reporting mechanisms. Emphasis will be placed on the importance of thorough, streamlined auditing reports and leveraging internal audits as a training tool for continuous improvement.

Preparing for Regulatory Inspections

In preparation for inevitable regulatory audits, the seminar will provide participants with strategies to enhance their current audit programs. Discussion will include how to integrate virtual audits effectively and the best practices for responding to the notice of an impending FDA inspection. Additionally, the course will address the discrepancies often encountered between FDA inspections and other international regulatory assessments.

Rising Standards and Compliance Objectives

Regulatory expectations are consistently climbing, and the demands for compliance now frequently include considerations such as Part 11 and cybersecurity measures. The seminar will contextualize these evolving requirements within the audit process, aiming to align a company's pinternal practices with the escalating inspection criteria. The seminar is poised to become an invaluable resource for pharmaceutical companies seeking to refine their audit strategies, align with regulatory expectations, and effectively manage the complexities of FDA compliance. With a proactive approach to inspection readiness, companies can fortify their standing in a competitive and heavily scrutinized industry.

Speakers

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.

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