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:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$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.

Learning Objectives:

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
  • Purchasing
  • Process owners
  • Quality engineers
  • Production Managers
  • Quality Engineers
  • Production Managers
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction, Purpose, Objectives, & Scope
    • Importance of quality philosophy
    • Purpose and Objectives
    • Scope
    • 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)
    • EU
    • 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
      • Confidentiality Agreements
Day 02(8:30 AM - 4:30 PM)
  • 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.
    Starting Out:

    • 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
    • “Touring”
    • 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)
    • Entertaining
  • 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
    • Disqualification
    • Supplier/Contractor File
    • Supplier History
  • Finale
    • Case studies not already covered
    • Class Exercise
    • Warning letters not already covered
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Howard Cooper

Howard Cooper
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 issues.

Howard particularly enjoys and encourages class participation and discussion during the presentation.

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Local Attractions of Tampa, FL

Museum of Science

Museum of Science & Industry (MOSI)

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum

Salvador Dali Museum

Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.

Tampa Museum of Art

Tampa Museum of Art

Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.

Craftsman House

Craftsman House

Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island

Adventure Island

Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.

Busch Gardens

Busch Gardens

At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.

Florida Aquarium (The)

Florida Aquarium (The)

The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.

John's Pass Village

John's Pass Village

This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.

Lowry Park Zoo

Lowry Park Zoo

Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.

Moccasin Lake Nature Park

Moccasin Lake Nature Park

If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.

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