Course Description:
In the development and commercialization of biopharmaceutical products, historically most of the R&D and GMP attention has been focused on the manufacturing process and production facility. However, there has always been a vital role for the ‘other half’ of the equation: analytical testing and laboratory operations.
The global emergence of biosimilar products – where significant attention is given to analytical characterization and comparability – has turned a brighter spotlight on the analytics. It is expected that rationale for the design and execution of analytical studies, the selection of and validation of appropriate method technologies, the assessment of drug substance and drug product stability, and the establishment of meaningful, supportable specifications will be justified in regulatory dossiers.
This two day interactive course on CMC requirements for biopharmaceutical products will focus on the types of analytical CMC studies that are critical to the successful review and approval of product IND/IMPD and BLA/MAA filings. It will also discuss the vital role of laboratory quality systems in assuring the reliability and integrity of the data generated to demonstrate product comparability, quality and stability.
Complementary USB Drive for first 20 Registrations: Register Now and get a complementary USB drive containing over 200 global guidance documents and industry white papers applicable to the information discussed. Additionally attendees will be given links to many places where they can continuously update their knowledge of the topics covered.
Learning Objectives:
Upon completing this course on analytical CMC regulations, participants will:
- Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements
- Understand why requirements for biotech products are so different from those of chemical products
- Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents
- See how to implement a staged approach to establishing specifications for release and stability testing
- Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability
- Select the appropriate methods for release and stability testing
- Design suitable qualification and validation exercises for method intended uses
- Establish stage-appropriate ICH stability protocols
- Learn the tiered approach for managing product reference standards
- Recognize how much R&D data are exposed to regulatory scrutiny
- See the new regulatory guidance on quality agreements with contract testing labs
Who will Benefit:
This course is designed for people tasked with designing, conducting, auditing, or managing key CMC studies; writing dossiers or responding to communications for submission to regulatory authorities; preparing for or conducting inspections of analytical labs for biotech or biosimilar products. Following personnel will benefit from the course:
- CMC study directors
- Method development specialists
- Process development specialists
- R&D scientists
- QC technicians
- QC laboratory managers
- Stability program managers
- QA professionals
- CRO personnel
- Technical writers
- Laboratory inspectors
- Regulatory professionals
- Compliance professionals
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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Nadine M. Ritter Senior CMC Consultant at Biologics Consulting Group, Inc Nadine M. Ritter,Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies. For over 15 yrs, she has contributed data to numerous US and international regulatory IND/IMP and BLA/NDA/MAA filings. She also has considerable experience conducting audits of sponsor and contract laboratories worldwide. She is a member of several professional analytical organizations, and is frequently invited as a speaker and writer on analytical and stability issues. |
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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).
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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.
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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.
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