Supplier and Contractor Qualification and Control: 2-Day In-Person Seminar
Howard Cooper, President, EQACT, INC.
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This two-day course focuses on the processes associated with the acquisition of products, materials and services that fuel and support the organization’s product manufacturing and marketing. These cross-functional processes are complex and result in conflicting objectives between decision-makers. Management is responsible for organizing and providing resources and the more they understand, the more effectively they can manage. This course begins with a discussion about quality and compliance and some of the regulations pertinent to supplier/contractor qualification and control. The primary regulations are:
- Part 211, Subpart E-Control of Components and Drug Product Containers and Closures, ICH Q7A, Section VII, Materials Management Part 820, Subpart F, Purchasing Controls.
- ISO 13485:2016, ISO 9001:2015, pertinent ICH & IMDRF (formerly GHTF) documents and pertinent FDA guidance documents. Quality concepts from “quality gurus” will also be presented.
- Contract Testing Laboratories
- Part 58, Good Laboratory Practices, (GLP) contractors.
Next, the course discusses how functions and personnel must be organized and an infrastructure established to ensure the “building blocks” of the products meet processing requirements and produce products that meet customer requirements. Management provides resources that ensure that these activities are properly managed and personnel are in place who have experience, qualifications, and knowledge to carry out the responsibilities. Procedures must exist that provides direction and structure to the process.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
After the organization and infrastructure are in place, it must be implemented. So the next topic is a very detailed presentation and discussion of the entire qualification process beginning with the creation of the specification followed by a series of tasks that include testing material samples, researching and analyzing potential candidates, planning and conducting an audit. The audit data must be analyzed and used to form a conclusion concerning the qualification status. These activities must be monitored.
Finally, case studies, warning letters, experiences of the speaker will be presented. Class activities will encourage your participation.
Note: Attendees will receive electronic documentation that includes an SOP for auditing and qualifying suppliers and contractors, supplier rating, audit and qualification tracking form, targeted industry specific questionnaires, samples of specification’s forms and other boilerplate documents.
This course is designed for personnel with all levels of material and supplier experience. Upon completion of this course, attendees will:
- Understand that all the regulations have similarities and differences; and similarities outweigh the differences.
- The requirements provided by each GMP regulation or even collectively do not meet minimum requirements in navigating today’s supply chain or achieving compliance. Therefore, they must be augmented by combining the total GMP requirements and applying quality concepts outside the regulations.
- Learn and understand the terminology as well as the regulatory and quality concepts.
- Suppliers and contractors are not equal. Suppliers produce items used in processing to manufacture products. Contractors perform operational processes that are part of the manufacturer’s inherent responsibilities or outsourcing.
- Understand the scope of qualification activities includes any item that touches the process such as filters, cleaning agents, lubricants, etc. Qualification tracks are less strenuous for these items.
- Be aware virtual and brick-and-mortar business structures require altered approaches to S/C. Virtual companies rely almost wholly on contractors. Brick & Mortar companies may use contractors to augment some processes. However, virtual companies retain many responsibilities when contracting.
- Quality agreements must be in place when outsourcing and contracting.
- Auditor certifications are helpful in learning audit techniques and objectivity. However, it is no guarantee of auditor success because experience, knowledge and understanding outweigh certification without these factors
- Understand the responsibility to protect your company and if you make observations that could negatively impact the company, it is your responsibility to see the issue is addressed.
- Understand that supplier qualification is a part of the material validation process. Process must exist for creating, developing, and changing material specifications in order to maintain material integrity. The supplier must also sign off on the specification including a change notification to the firm.
- Understand the qualification of the supplier’s quality control testing operations is key to protect the integrity of the material. For critical items, collaborative testing between the supplier and the firm is required.
- Must be aware reduced testing can only occur after a robust qualification and material validation has successfully been completed. This is a separate qualification in the sampling plan must be scientifically sound with established risk standards. Examples of these factors include criticality of the item, volume, difficulty of test method, supplier history, and analytical testing results.
- An established criterion must exist for qualifying suppliers.
- A process must exist for disqualifying suppliers.
Who will Benefit:
- Because the qualification process is multi-functional, Quality, Production, Purchasing, R&D, Document Control, etc. will benefit by attending this seminar.
- Management can better understand their responsibilities as they oversee multi-functional characteristic S/C qualification and control.
- Those functions who have the greatest potential to gain from this seminar include, for example:
- Audit Team Leaders will gain insight into the multi-functional processes they lead
- Audit Team Members will gain insight that will help them better understand the role and how the process functions leading to potential increased responsibility.
- Provide knowledge to auditors seeking certification
- Quality (QA & QC) and Regulatory Affair are the major drivers of qualification
- QC will learn more about the requirements for testing & sampling activities, material qualification, and incoming controls.
- QA will gain knowledge and insight in their decision-making concerning specification approvals, evaluating suppliers/contractors, corrective action plans, material validation,
- Documentation Control will gain insight on the processing of material specifications, establishing supplier files, and handling of audit related documentation
- Purchasing will better understand their role as an intermediary between the company and the supplier and contractor.
- R&D will gain insight into developing both material and product specifications and importance of qualifying suppliers in the early stages of development.
- Production owns the conversion process and therefore must understand the importance of the qualification of suppliers and contractors as well as evaluating their performance.
- For contractors providing outsourcing to the medical industry, it provides guidance on fulfilling the client’s needs to meet compliance requirements.
- Suppliers to the industry will gain insight and knowledge that will help them understand and meet their client’s needs.
- Examples of positions that has the potential to benefit include:
- Senior Management
- Management Representative
- Quality Auditors
- Senior Quality Managers
- Quality Professionals
- Regulatory Professionals
- Compliance Professionals
- Regulatory Affairs
- Regulatory Affairs
- Process owners
- Quality engineers
- Production Managers
- Quality Engineers
- Production Managers
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction, Purpose, Objectives, & Scope
- Importance of quality philosophy
- Purpose and Objectives
- Quality Versus Compliance
- Lifecycles-Product, Manufacturing, & Material
Regulatory and Quality Requirements (Components & Supplier Qualification and Control)
- Part 211 Finished Pharmaceuticals (1978)
- Part 600 Biological
- Part 820 Device GMPS (1978)
- Part 820-Quality System Regulation(QSR) (1997)
- Part 1270-1271
- International Conference on Harmonization (ICH)
- International Medical Device Regulators Forum (IMDRF) formerly Global Harmonization Task Force (GHTF)
- ISO 13485:2016 and& ISO 9001:2015
- Part 11
- Applicable FDA guidance documents
Developing and Implementing the Supplier/Contractor Auditing and Qualification Function
- Management Over-Sight
- Staffing & Organization-Quality Department and the Auditing Unit
- Audit Interaction Team
- Inter-Functional relationships
- Virtual & Brick-And-Mortar approaches to qualification
- Auditor certification
- Material Specification Development, Review, & Approval
- Material-Product-Supplier-Contractor DB
- Reduced Testing
- SOP & Policy-or SOP-Policy Combination (Flowchart Format)
- Supporting Forms & Documents (Examples)
- Audit Tracking Qualification Form
- Targeted questionnaires (10)
- Audit Schedule
- Supplier/Contractor Rating Sheet
- Quality Agreement
- Audit Flow Worksheets
Flow-charting the supplier and contractor qualification and control process.
Note: Early in the process, potential S/C must have an approved final, draft, or developmental written specification.
- Begin a targeted search for potential suppliers or contractors (Or existing suppliers)
- Research and collect data to further differentiate the potential candidates
- Analyze data to determine strongest candidates
For the strongest candidates do the following in tandem:
- Test samples, prototypes, models, drawings, to confirm meeting specification requirements
- Send a targeted questionnaire (i.e. Component, specialty chemical, API, and finished device,
- Using the data collected, make a decision on the tasks required for qualification
- If paper audit is required, follow paper audit protocol
- If on-site audit is required, go to on-site audit protocol
Preparation and Planning-Audit Leader, Audit Team,
- Developing a working relationship by developing a “mutual agenda,
- Learn as much as possible about the auditee prior to the audit
- Documentation review for audit
- Audit Logistics
- For contractors, make quality agreements a part of the agenda
- Using the laboratory testing, research, and the targeted questionnaire to structure the agenda
- Preparing the opening meeting presentation.
- Finalize the agenda and make audit team assignments, as applicable.
- Final planning for the audit
Conducting the on-site audit
- Opening Meeting
- Quality System quality system review
- Quality System documentation review
- The Laboratory, Utilities, IT, Documentation Management
- A note on multiple day audits
- Audit Team Meetings
- Closing Meetings, presentation of findings, & corrective action plans(ROT)
- Handling Difficult Situations
- Update meetings (dependent on audit length)
Analyzing the data, corrective action plans, and preparing report
- Audit Team post-audit wrap up
- Responsibilities for preparation
- Classifying criticality of findings
- Plan Follow-Up as maybe needed
- Audit Team-Audit Group review and approval of report
- Three most probable outcomes—qualified, qualified with conditions, not qualified
- Re-audit Follow-up
- Report Distribution
- Boilerplate responses
- Send Report
Response to the report
- Review response and note any disagreements
- Negotiate but do not yield
- Follow-Up & Verification
- Tracking corrective actions
Maintaining and Monitoring
- Audit reports filing and access
- Audit Schedule
- Periodic Reports to Management
- Periodic meeting with management
- Supplier/Contractor File
- Supplier History
- Case studies not already covered
- Class Exercise
- Warning letters not already covered
Meet Your Instructor
President, EQACT, INC.
Howard Cooper is an independent quality and regulatory consultant with more than 40 years of hands-on, tactical, and strategic experience designing, implementing, managing, and remediating device, pharmaceutical, and biological quality systems. His technical background helps him understand and apply the technology, his political science helps him understand the regulatory process, and his work on an MBA provides a business perspective. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Certified Quality Auditor (CQA).
After teaching high school science, Howard joined Anheuser-Busch as a Management Quality Trainee to begin his FDA experience. His ability to quickly learn and apply quality principles resulted in promotions to quality supervision and management. He transferred this experience to a medical device contractor about the time FDA medical device regulations were on the horizon. He applied his comprehensive quality experience to revamp both quality and operations to meet all regulations the ride for the medical device amendments.
As a change agent, he enjoys challenging and persuading others to think outside the box to view quality as a positive and energetic force that can make the difference between business success and failure. He emphatically emphasizes the importance of competent and confident people who develop strong working relationships as they work to constantly improve the organization.
Since becoming a consultant in 2004, he has focused on startup and problematic operations using his “change agent mentality”. During presentations, he frequently relates these experiences to illustrate how he mitigated and resolved
Howard particularly enjoys and encourages class participation and discussion during the presentation.
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