Course Description:
Analytical methods ensure quality of drugs and biologics. During last 2 decades, paradigm for quality of pharmaceutical products has shifted from ensuring quality by testing representative samples to building quality during manufacture of such products, leading to the concept of Quality by Design (QbD). This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality.
Methods play a critical role in development and manufacture of drugs and biologics and should be considered as a "Life Cycle" approach throughout the life cycle of a pharmaceutical product. The methods must be suitable for intended purpose during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. All methods used in manufacturing operations must be maintained in a compliant state with acceptable method performance during life cycle of the product. This course will go into details of the life cycle of analytical methods, including verification, qualification and validation of methods for various stages of product development and for various purposes during manufacturing operations. Appropriate methods attributes and parameters will be discussed that need to be monitored (tracking and trending) to evaluate method performance.
Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Biological methods or bioassays with large inherent variability have challenges in developing appropriate method so that these are suitable for intended purpose. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. This course will further go into the challenges, regulatory expectations and myths about bioassays with focus on developing suitable bioassays for intended purposes.
Seminar Fee Includes:
One of the challenges in developing cutting edge products, including cellular, tissue, gene therapy products, vaccines and blood products is developing appropriate potency method for these products. Often protective mechanisms for such products or surrogate markers for efficacy of such products are not clearly defined. There are examples of use of highly variable animal based methods as potency tests, which are sometimes poor indicators of human efficacy. In such cases, the concept of consistency in manufacture is employed to develop appropriate potency test, which may be a single test or a combination of tests. This course will go through regulatory expectations in developing potency tests for biological products.
Critical Reagents, Reference Standards and Internal controls play an important role in ensuring validity of results generated by analytical methods, particularly biological methods, and also to ensure acceptable performance of the method over time. This course will also discuss about selection and qualification of critical reagents, reference standards and internal controls for generating reliable results.
Throughout the course, specific examples with regard to achieving regulatory compliance during inspections, audits and review of methods sections, as part of license applications or supplements to license applications will be discussed. More importantly, information on the design of robust methods "Suitable for Intended Purposes" will be provided to mitigate risks of mistakes/errors and out of specification (OOS) results.
Learning Objectives:
Upon completing this course the participants will understand:
- Ensuring quality by the new paradigm of Quality by Design(QbD)
- Building quality in the product
- Analytical Method Life Cycle during Product Development and commercial Manufacturing
- Regulatory Expectations and Requirements for the Methods during Product Development
- Methods Verification, Qualification and Validation with Examples
- Methods Validation Characteristics – Robustness, Specificity, Accuracy, Precision, Linearity, Limit of Detection, Limit of Quantitation, Range
- Tracking and Trending of Method Performance
- Challenges with Biological Methods or Bioassays
- Myths and Regulatory Expectations about Bioassays
- Potency Tests for complex Biological Products
- Regulatory Expectations for a Potency test
- Role of Critical Reagents, Reference Standards and Controls and their Development and Qualification
- Risks and Inherent Variability of Analytical Methods
- Designing Methods “Suitable for Intended Purposes” to Mitigate Risks due to Errors and Out of Specification (OOS) Results
- How to Continuously Monitor Method Performance and achieve sustainable compliance of methods for regulatory requirements?
….much, much more
Who Will Benefit:
- Pharmaceutical Industry
- Biotech Industry
- Managers and Scientists involved in Drug Development
- Analytical Development Scientists involved in method development, qualification and validation of methods
- Quality Control Scientists Involved in Performing Routine Testing and Monitoring Method Performance
- Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on Investigations, Change Control, etc.
Course Outline:
| 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 – Ensuring Quality by Testing Representative Samples and Building Quality in the Product
Role of Analytical Methods in Ensuring Quality
Analytical Method Life Cycle during Product Development
|
Challenges in Developing Testing Criteria for Biological Products
Biological Methods or Bioassays – Regulatory Expectations, Myths
Potency Test for Complex Biological Products
Inherent Method Variability in context of Design of a method that is “Suitable for Intended Purpose”
Critical Reagents, Reference Standards and Internal Controls
Monitoring of Method Performance – Tracking and Trending
|
Meet Your Instructor
 |
Rajesh Gupta Visionary Scientific & Compliance Consultant and Former Deputy Division Director and Lab Chief, Div of Product Quality, FDA CBER Rajesh K. Gupta has a Ph.D. in microbiology and is the Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years' experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry. At FDA, CBER, he was a Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
|
Local Attractions
Singapore Zoo
Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.
Night Safari
The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.
Universal Studios Singapore
Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!
Singapore Flyer
The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.
Underwater World, Singapore
Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.
Boat Quay
Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.
Sentosa Island
Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.
