Eastern Analytical Symposium

EAS Webinars for 2015

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EAS has partnered with Pharma Webinars (a division of the Tungsten Shield Group) to bring new online professional training to the analytical science community. Our webinars are not pre-recorded but live and interactive. There will be time for questions after the presentation. Group rate available; see below for pricing. We are offering the following two webinars: Protein Analysis on Feb. 19th and Elemental Impurities on April 8th (details below).

Protein Analysis: A Comprehensive Overview of Analytical Testing
and Specifications & Latest Regulatory Requirements

Date: Thursday, February 19, 2015 
Time: 9:30 – 11:30 AM ET (New York Time)
Instructor: Robert Johnson, Pharmaceutical Consultant
Course Description: click here for specific details about this webinar
Over the past 30 years biotechnology has revolutionized medicine. This revolution will continue into the future with even more advanced treatments and technology. Many of these medicines will involve proteins, which are the fundamental building blocks of cells and also extensively involved in cell function.

This course will provide an overview of:
• Basic biotechnology to facilitate an understanding of the nature of proteins.
• Manufacturing technology for proteins.
• Analytical technologies for characterizing proteins.
• Analytical controls including typical specifications for proteins.
• Regulatory requirements and guidances for proteins.
It has been said that “you cannot control what you cannot measure.” This course is intended to provide an overview of the types of analytical controls available for the manufacture of proteins. Furthermore, the course will provide insight into the underlying technologies used for protein manufacture including both protein expression in various cells and the related purification processes necessary to manufacture drug substance (active pharmaceutical ingredient) and drug products. Because most proteins are sterile injectable products, information will be provided related to the special requirements related to the delivery of sterile injectables. Finally an overview of available regulations and guidance will be provided.
The objective of this live training webinar is to discuss the test method lifecycle and how concepts discussed in the process validation guidance apply to test method validation.

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Elemental Impurities Compliance for the Pharmaceutical Industry: An Overview of the New Compendial Requirements and Analytical Strategies

Date: Wednesday, April 8, 2015
Time: 9:30 – 11:30 AM ET (New York Time)
Instructor: Tim L. Shelbourn, Research Scientist, Eli Lilly and Company
In 2005, the United States Pharmacopeia (USP) began the process of replacing the sulfide precipitation based Heavy Metals general chapter <231> with atomic spectroscopy based standards, Elemental Impurities chapters <232> and <233>. Going on a decade later, these standards are set to become regulatory enforceable-the most recent published implementation date provided by USP is December, 2015. These standards represent a dramatic departure from the venerable Heavy Metals test (used both by the US and in Europe) in that a specific list of elements is provided. Each element is associated with a specific permissible daily exposure limit (PDE’s) for various routes of administration. More recently, the International Conference on Harmonization (ICH) has published the Q3D document, a Guideline for Elemental Impurities, which is anticipated to be implemented in early 2016.The subject is of principle importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing. If the manufacturer’s compliance strategy involves testing, there are many things to consider with regards to selecting the correct analytical technique (atomic absorption, ICP emission spectroscopy, ICP mass spectrometry or XRF).The objective of this live training webinar course is to provide an understanding of the new standards and guideline, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.
Learning Benefits:
-An overview of USP <232> and <233>.
-Reviewing ICH Q3D.
-Risk assessments.
-Compliance strategies.
-Analytical considerations and selecting the best technique.
-Analytical method validation.

Registration:
click here to register 1 or more attendees for one or both of these live webinars
Prices are as follows per webinar:

Note: As an added value to students,  we will be providing students and academia with an additional 40% discount off the regular registration fees.

The discount will be automatically applied to each registration if received from a valid email and address of a recognized educational institution or research organization.

1 Attendee: $ 305
2 Attendees: $ 425
3 Attendees: $ 510
4 Attendees: $ 625
5 Attendees: $ 685
6 Attendees: $ 745
7 Attendees: $ 815
8 Attendees: $ 895
9 Attendees: $ 945
10 Attendees: $ 995
11 Attendees: $1,023
12 Attendees: $1,092
13 Attendees $1,170
14 Attendees: $1,246
15 Attendees: $ 1,305
Group Over 15 Attendees: $ 85.00 per Attendee

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