Vendor Qualification and Audit Training
About This Course
Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but do not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.) Any supplier qualification program must include two critical components:
- Clearly defined specifications/requirements for all of these goods or services being purchased, and;
- Objective evidence to show that your requirements are being consistently fulfilled.
This eight-hour vendor qualification audit training will help you improve quality in your facility. It is designed for those who already have a basic understanding of dietary supplement GMPs and the knowledge and skills necessary to qualify suppliers.
Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the auditing process and the skills and techniques needed to get the most from these activities. The skills and techniques learned are independent of the type of auditing or the standard being audited and will be useful when conducting internal audits and performing audits of suppliers.
Key Learning Objectives
On conclusion of this course, you will have an understanding of the following:
- Regulations that apply to vendor qualification (21 CFR 111)
- Food Safety Modernization Act (FSMA)
- Impact of FSMA on supplier qualification
- Risk assessment and risk management
- Supplier monitoring activities
- On-site audit strategies and requirements
- Managing the audit process effectively before, during and after
- The consequences of noncompliance
Who Should Attend?
This course is valuable for QA/QC, regulatory and compliance, laboratory, and other key personnel who are in charge of or a part of implementing a new or modifying an existing vendor qualification program into their dietary supplement companies’ operations. The course would also be useful for purchasing and production managers, who may be involved in the vendor determination process and could benefit from understanding some of the elements in qualifying a supplier.
Instructors
Course instructors will be selected from the following:
Shawn Ludlow. Shawn Ludlow is a well-established NSF GMP instructor. He has created several third-party certified quality programs compliant with 21 CFR 111, ISO 9001:2000 and FAMI–QS.
With an undergraduate degree in chemistry, master’s degree in public health and experience working as an analytical chemist for several years, Shawn found his education and work experience combination to be a natural fit for dietary supplement manufacturers looking to improve their quality programs.
Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.
Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.
Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.
Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.
Jennifer Alfrey - Jennifer has a master’s degree in nutrition and over 25 years of experience in the dietary supplement and cosmetic industries. Her experience ranges from product innovation to global regulatory compliance with experience in formulating, developing, and registering nutrition and cosmetic products in over 150 different countries.
Jennifer has also successfully built cGMP compliant quality management systems from the ground up for dietary supplement manufacturing operations. She has launched quality systems that include compliant documentation of procedures, MMRs, specifications, complaints, laboratory testing, test method development and manufacturing processes.
Additional Recommended Courses
CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many experienced auditors decades to develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. During the course, learners will plan, perform, and report audits based on case studies that simulate internal, supplier, and third-party audits utilizing MDSAP audit criteria. Learners will participate in simulated auditing exercises that include planning and performing audit activities, evaluating audit evidence, and documenting audit findings.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).
Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.
By the end of this course you should be able to:
· Describe the purpose of:
- Quality management systems
- Quality management system standards
- Management system audits
- Third-party certification
· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018
· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.
Price: $2800.00
MDSAP Internal Auditor Training
This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.
This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.
An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.
This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
- Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
- Recognize the competency and training requirements for AO auditors
- Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
- Calculate audit time and plan an MDSAP Lite internal audit
- Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
- Identify post-audit MDSAP activities including NC grading
- Recognize the outcomes and goals of an MDSAP audit
Price: $1200.00
EU IVDR Internal Auditor
This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR). The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.
This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Identify Key Articles and Annexes of the EU IVDR
- Recognize Intent of Requirements as Described in Recitals
- Identify Classification Implementing and Classification Rules
- Identify General Safety and Performance Requirements (GSPRs)
- Recognize Content of Technical Documentation
- Identify Post-Market Surveillance Reporting and Vigilance Obligations
- Recognize one EU IVDR Audit Model
- Plan an EU IVDR Audit
- Document Nonconformities against EU IVDR requirements
Who should attend:
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
Price: $1200.00