The Vendor GMP Qualification Audit: Ensure Your Vendors Meet Your Compliance Standard
You have worked hard to ensure your therapeutic products meet the highest levels of quality and compliance. Like most firms, your success is dependent on several outside vendors (e.g. manufacturers, testing, packaging, labeling, storage, shipping, etc.), all of whom you rely upon to meet your high standards. Despite your best internal efforts, any substandard performance by your partners can result in lost revenues, non-compliance, and worse – a loss of consumer confidence. Furthermore, global regulatory agencies have asserted that firms are “only as compliant as their vendor partners.”
Fortunately, there are key auditing steps that will result in successful outcomes, helping you form lasting partnerships and avoid getting stuck in a costly and destructive relationship with the wrong vendor. By attending this interactive 90-minute session, you will learn practical ways to address the audit portion of the GMP qualification process.
Through the use of examples you will learn the following:
- Planning the audit: mapping out steps to get the critical information you need
- What needs to be audited, the tools at your disposal, and tips for an effective close-out meeting
- Audit reporting – learn to concisely and accurately document your findings
- Observation and follow-up techniques that will save time and ensure consistency throughout the process
Additionally, vendors (manufacturing, testing, labeling, packaging, distributing, warehousing) will learn about:
- Audit preparation procedures
- Document selection to demonstrate SOP compliance
- Tools to manage the audit
- Dos and don’ts of audit hosting
- Responding to audit findings
- Remediation techniques
This course would be valuable for those in the life science industry who are responsible for conducting GMP audits. This may include third party auditors, QA/QC, Manufacturing, and Regulatory/Compliance personnel who are actively involved in the audit process or who want to become an auditor. In addition, vendors and suppliers who are audited will find this course extremely useful in providing recommendations for audit preparation and management tools.
Brooke Moody, an independent contractor with Polaris Compliance Consultants, Inc., has over 13 years of cGMP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), Clinical Research Materials, and Finished Product. During her career, she has been responsible for the development and maintenance of quality systems, including both internal and external auditing programs as well as training programs. She has conducted numerous quality audits including routine audits, vendor/supplier qualification audits, and for-cause audits. She has held positions as Senior Quality Associate and Quality Assurance Manager at contract service providers (including manufacturing and testing facilities) as well as pharmaceutical companies and consulting firms. Mrs. Moody holds a Bachelor of Science degree in Chemistry from Florida Atlantic University.