This seminar will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.
To aid the learning process, the principles of QbD will be applied to a specific program, implementation of the new Elemental Impurity guidelines, ICH Q3D. Practical implementation of ICH Q3D requires a risk based approach, but the fundamental challenge is to find a means to categorize risk. This means an exhaustive assessment of all the components of manufacturing including API, excipients, water, manufacturing equipment, processing aids, and container closure system to determine their contributions to all elemental impurities. Alternatively, it is possible to simply do final product testing on finished dosage forms. This carries the risk, however, that failure here involves discarding the batch.
Learning Objectives:
Upon completing this course participants should:
- Understand the principles behind using QbD to develop a pharmaceutical product including
- Understand what is meant by Quality be Design
- Understand the benefits from applying a QbD approach
- Provide key steps to implement a QbD program
- Understand the important tools used to implement a QbD approach
- Understand how to utilize a risk-based approach to address implementation of elemental impurities requirements
Areas Covered:
ObD principles discussed include:
- Quality Target Product Profile (QTPP)
- Risk Assessment
- Using Models
- Design of Experiments
- Developing a Design Space
- Process Analytical Technology (PAT)
- FMEA and Control Plan
- Target Operational Profile
- Control Strategy
- Elemental Impurities (Q3D) Risk Assessment Strategies
Who will Benefit:
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production managers
- Manufacturing engineers
- Production engineers
- Process owners
- Quality engineers
- Quality auditors
- Development professionals
- Senior development managers
Topic Background:
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.” Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Introductions and QbD Overview
- QbD Overview
- What is QbD
- What does a QbD program look like
- Quality Target Profile Introduction (QTPP)
- QTPP ICH background
- Factors to consider
- Implementation
- Introduction to Risk Evaluations and Early Risk Assessments
- Description
- Information flow
- Tool Use example
- Benefits
- Integrating the QTPP and risk assessments into your development program
- Mapping QTPP and Risk Assessments into the scientific investigations
- Prioritizing efforts
- Identifying Critical Quality Attributes
- Design Space Development
- Definition
- Concepts to develop a design space
- Graphical representation
- Later Stage Risk Evaluations. (FMEA)
- Purpose of an FMEA
- Design and application
- Designing the Control Strategy
- Definition
- Approach for developing
- Technology Transfer
- Definition and Importance of Technology Transfer
- The use of gated review processes
- Tools and templates
- Elemental Impurities: Background
- EI limits and comparative requirements between ICH vs FDA
- Calculations of Dosage Form Limits
- EI Prioritization by toxicity
- Various Strategies for Implementation
- Test every finished batch for all EI
- Risk Based Assessment
- Common document approach
- Where to focus attention
- Component approach vs final product testing
- FDA guidance
- Decision-making based on safety, economics, product risk
- Required documentation, submissions
- Regulatory
- Product Risk Assessment
- Results of testing conductedv
- Regulatory submissions-new specs, methods, validations
- Quality
- New GMP procedures to demonstrate compliance
- Change management controls
- Regulatory
- Manufacturing Process Analysis
- Water
- API
- Excipients
- Stainless transfer tanks and lines
- Container Closure System
- Analytical Testing, Validation, Transfer
- Placing an R&D method in a plant environment
- Instrument selection criteria
Steven Laurenz,
Principal Consultant, BioPhia Consulting Inc
Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.
Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium.
Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics
Barrett Rabinow,
Ph.D, Consultant
Barrett Rabinow was previously a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he worked for over 39 years. He received his A.B. from Cornell University in 1968 and a Ph.D. in Chemistry in 1974 from the University of Chicago. From 1975-1976, he completed postdoctoral fellowships in electrochemistry, and in clinical chemistry at Michael Reese Hospital, Chicago. From 1976-1977, he served as Director, Clinical Chemistry Laboratory, Norwegian-American Hospital in Chicago. He then joined Baxter Healthcare Corporation in 1977. His positions of increasing responsibility led to the position of Director, Chemistry, where he oversaw chemistry, particle science, material science, polymer technology, and manufacturing troubleshooting for the parenterals solutions business. Dr. Rabinow has been active in industry task forces, organized by the Parenteral Drug Association, AdvaMed, Association for the Advancement of Medical Instrumentation, and the International Standards Organization as well as collaborative studies with USP, FDA, and NIH. For six years, he identified and evaluated new business opportunities, leading to Baxter acquisitions. He has developed lifecycle reformulations of drugs with new pharmacological characteristics in the area of nanosuspensions and stereoisomers. He led a team developing innovative lean stability testing protocols for parenteral solutions. Dr. Rabinow has numerous patents to his credit in the area of pharmaceutical formulations, nanoformulations, and biomaterials. He has authored four book chapters and over 40 articles, in the areas of physical-organic chemistry, clinical and analytical chemistry, trace metals, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology and drug targeting.
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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
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
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 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
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
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)
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
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
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
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.
