UPCOMING WEBCASTS Tuesday, August 13, 2008
11am ? 12pm ET Regulatory Strategies to Accelerate First in Man Studies
Richard E. Lowenthal, MS MSEL, President, Pacific-Link Consulting
Sign Up Now>> This seminar will focus on Regulatory strategies to accelerate first in man studies during early drug development. The discussion will provide some insight on several successful strategies for initiating first in man studies, including Exploratory INDs, regional flexibility and indication based strategies. Case studies for several approaches to initiating first in man studies in an accelerated fashion will be presented.
Tuesday, August 14, 2008
11am ? 12pm ET Computer Validation - what is important?
Flemming Simonsen, Senior Director - Global QA, G(IT)P
Ferring Pharmaceuticals
Sign Up Now>> This seminar will focus on Regulatory strategies to accelerate first in man studies during early drug development. The discussion will provide some insight on several successful strategies for initiating first in man studies, including Exploratory INDs, regional flexibility and indication based strategies. Case studies for several approaches to initiating first in man studies in an accelerated fashion will be presented.
Tuesday, August 19, 2008
11am – 12 pm ET
Case studies in Quality by Design, QbD, with Design of Experiments, DOE, from Journal Articles Published in Pharmaceutical Technology
Mr. Lynn D. Torbeck,
Principal Consultant, Torbeck and Assoc., Inc.
Sign Up Now>>
Tuesday, August 20, 2008
11am ? 1pm ET Understanding the Standard Setting Process of the United States Pharmacopeia and National Formulary Part 1 & 2
Susan Schniepp, President,
Schniepp and Associates
Sign Up Now>> This training series will focus on the standard setting process of the United States Pharmacopeia and National Formulary. This complex process will be broken down into individual elements so the student can understand how the process works, how it impacts their work and how they can participate in the process. In addition, the series will also explore common misinterpretations of the USP General Notices, dissecting a monograph and validation and verification concepts for the methods in the USP/NF.
The USP has a number of processes that relate to the setting of standards for the United States pharmaceutical market. These processes included the USP Convention, Resolutions, Public Comment, and Monograph Submission. After the class the participants should be able to:- Understand the Standard Setting Processes and how it impacts their operations
- Understand how they can participate in the standard setting process and represent their companies viewpoint
- Understand how trade organizations impact the process
- Understand method validation and verification concepts as they relate to USP/NF monographs
- Dissect a monograph and identify all tests that need to be performed to be compliant to the USP/NF
- Interpret the USP/NF General Notices
Thursday, August 21, 2008 from 11am to 12pm ET
11am ? 12pm ET Developing and Validating Dissolution Test Procedures
Michael E. Swartz, Ph. D., Research Director,
Synomics Pharmaceutical Services
Sign Up Now>> In-vitro dissolution performance tests for oral dosage forms, such as tablets and capsules, are used to assess the lot-to-lot quality of a drug product, guide development of new formulations, and to ensure the product quality and performance after changes in the manufacturing process, e.g. moving to a different site and/or scale-up. Like any performance test performed in a regulated environment, the dissolution procedure must be properly developed and validated. This seminar discusses the general concepts and highlights some specific method validation guidelines used in developing and validating dissolution test procedures using both UV and HPLC for sample analysis
Tuesday, September 9, 2008
11am ? 12pm ET Spectroscopic Identification of Raw Materials for Pharmaceutical and Nutritional Supplement Industries
Frederick H. Long, Ph.D. , President,
Spectroscopic Solutions, LLC
Sign Up Now>> The identification of raw materials is an important quality issue for both the pharmaceutical and nutritional supplement industries. The US FDA has recently mandated that nutritional supplement companies verify the chemical identity of incoming raw materials. The cost of raw material testing using traditional wet chemical methods can be high in terms of both money and time. Spectroscopic methods such as NIR, FT-IR, and Raman are a scientifically valid and cost effective method for raw material testing. New spectrometer technologies are making spectroscopic testing an attractive alternative. The quantitative testing of raw materials will also describe. This seminar will review the scientific and regulatory issues in this area. The advantages and disadvantages of different technologies will be discussed.
Tuesday September 9, 2008
2pm – 3pm ET Recent Trends In The Development And Manufacturing Of Fusion Proteins As Therapeutics
Frederick H. Long, Ph.D. , President,
Spectroscopic Solutions, LLC
Sign Up Now>> Fusion genes are created by joining two or more genes, each coding for a separate protein. Translation of the fusion genes results in a single polypeptide with the combined functional properties of the original proteins. Recombinant fusion proteins are created artificially by recombinant DNA technology for use in biological research or therapeutics. To participate in an active webcast about recent trends go to:
Thursdays, October 9, 16 and 23, 2008
12pm ET Series Title: Introduction to Chemometrics and Multivariate Analysis (MVA)
Frederick H. Long, Ph.D. , President,
Spectroscopic Solutions, LLC
Sign Up Now>> Spectroscopic methods such as NIR, FT-IR, and Raman are a scientifically valid and cost effective method for raw material testing. New spectrometer technologies are making spectroscopic testing an attractive alternative. The quantitative testing of raw materials will also be described. This seminar will review the scientific and regulatory issues in this area. The advantages and disadvantages of different technologies will be discussed.
This three part series of web seminars will cover the essentials of chemometrics: principal component analysis (PCA), partial least squares (PLS) and classification. Real world examples of MVA will be illustrated throughout the course. These seminars are intended for pharmaceutical professionals, who need a convenient way to learn about multivariate analysis. This series of web seminars assumes the attendee has only limited experience with statistics and spectroscopy. Event One Title: Introduction to Principal Component Analysis (PCA)
Event Synopsis:PCA is a powerful tool for the investigation of spectral and non-spectral data sets. We will begin with a discussion of the basic ideas of PCA including scores and loadings using some simple examples. Given a solid understanding of the fundamental ideas, we will then illustrate the use of PCA with several real world examples including spectral data sets.
Event Two Title: Introduction to Partial Least Squares (PLS) Analysis
Event Synopsis: PLS is widely used for quantitative method development and the prediction of constituent concentration values. PLS is an extension of PCA where both X (spectral) and Y (constituent) values are included in the analysis. The web seminar will cover the basics of PLS method development and optimization. Examples of PLS analysis will include moisture, assay and particle size. The optimization and validation of PLS methods will also be covered. The interpretation of critical graphs will be emphasized.
Event Three Title: Introduction to Classification Methods
Event Synopsis: The last seminar will cover classification methods. Classification is often done with spectral data sets. Classification methods such as SIMCA and PLS-DA can be used to identify materials, and to distinguish between very similar products or groups. Classification can also be used as a very sensitive quality assurance tool. The validation of classification methods will also be covered
ARCHIVED WEBCASTS Quality Systems in a Global Market
Sponsored By SGS Sign Up Now>> Available through June 12, 2009 Enhancing Tech Transfer from Development into cGMP Operations
Sponsored By Laureate Pharma Sign Up Now>> Available through April 28, 2009 Beyond Theory: How to Implement Changes to USP Chapter <467> Residual Solvents
Tuesday, April 22, 2008
Sponsored by Celsis Sign Up Now>> Available through April 22, 2009 |
For questions or more information please contact Jamie Carpenter at jcarpenter@advanstar.com or call 800-234-4535 |