UPCOMING WEBCASTS
 Tuesday, December 2, 2008
11am – 12pm ET
cGMP QC/QA Informatics Automation for Raw Materials Testing
John P. Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation
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The first critical step in a comprehensive cGMP “quality control” program is the evaluation and qualification of all raw materials used in the production process. Automating the process of method execution, data and metadata capture and regulatory documentation allows “right first time” and lean initiatives to be applied to quality operations for raw materials. This web seminar will outline the critical challenges facing 21st century pharmaceutical manufacturing at the raw materials stages with several case studies of how lab automation using a GMP ELN reduces review and approval cycle times by 50-75% from major pharmaceutical companies. Raw materials testing ensures that the raw materials used in the manufacture of pharmaceutical products are suitable for their intended use. Key issues include the identity, purity and quality of the raw materials on an on-going basis. Manufacturers approach the testing in various ways from simple identity testing (post qualification lots) to full monograph testing for each lot of supplied materials. Today, these tests are performed in a manual, paper-based process that consumes 50-75% more time and manpower then needed. Automation can ensure compliance and significant productivity gains in this required testing for all life science companies. This web briefing will outline a unique cGMP Electronic Notebook System and informatics platform to automate the standard USP-based test methods for raw materials testing. The system integrates all aspects of the testing procedures including presenting the approved test method to the analyst on a hand-held PC, connection of the system to testing instrumentation (balances, pH meters, AA’s, HPLC’s etc.) and automated data capture, cataloging and review processes. The system can stand-alone in your lab or integrate with ERP and/or LIMS systems for a full, paperless raw materials testing environment. Wednesday, December 3, 2008
2pm ET
GMP for Manufacture of Clinical Trials Material
Karen S. Ginsbury, B.Pharm. M.Sc. MRPharmS
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In July 2008, FDA released a final guidance on cGMP for Phase 1 Investigational Drugs, simultaneously publishing a final rule exempting manufacturers from the requirements of GMPs for commercial product (21 CFR part 211). This seminar will consider the legal and regulatory implications of this unique and apparently dramatic exemption in the context of the Federal Food Drug and Cosmetic Act. The FD&C Act requires that any drug produced for human use be manufactured in compliance with cGMP or it will be considered adulterated. Are you confused? This event will clarify the exact meaning of the new legislation.
The seminar will also compare the current requirements within the United States to those of the European Union. EU legislation requires full GMPs as well as Annex 13 for manufacture of Investigational Medicinal Products and Annex 16, batch certification by a Qualified Person.
For global pharma and biotech companies harmonization of GMPs seems to be receding into the distance. Listen to this lecture and separate myth from reality.
This webseminar will address the following topics:- Federal Register Final Rule exempting phase I material from 21 CFR part 211
- FDA phase 1 guidance: GMPs for Manufacture of Phase I material
- Annex 13 on manufacture of investigational products
- Annex 16: Qualified Person batch certification
- Current industry practice in the manufacture of clinical trials material: pre-clinical and phases 1 through 3.
 Wednesday December 10th, 2008
2:00 PM EST
The Impact of Harmonizing Microbial Testing - USP <61> Microbial Enumeration Tests
- USP <62> Tests for Specified Microorganisms
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This 60-minute webcast will feature a discussion by industry and regulatory experts on how to implement changes made by the harmonization of microbiology methods through changes to USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and the addition of USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, which take effect May 1, 2009. These chapters harmonize with corresponding chapters in the European and Japanese Pharmacopoeias.
Wednesday, December 10th, 2008
11:00 PM EST
cGMP QC/QA Informatics Automation for Raw Materials Testing
John P. Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation
Sign Up Now>>
The first critical step in a comprehensive cGMP "quality control" program is the evaluation and qualification of all raw materials used in the production process. Automating the process of method execution, data and metadata capture and regulatory documentation allows "right first time" and lean initiatives to be applied to quality operations for raw materials. This web seminar will outline the critical challenges facing 21st century pharmaceutical manufacturing at the raw materials stages with several case studies of how lab automation using a GMP ELN reduces review and approval cycle times by 50-75% from major pharmaceutical companies.
Thursday, December 11th, 2008
12:00 PM EST
PROCESS ANALYTICAL TECHNOLOGY (PAT): The Impact on Pharmaceuticals Manufacturing And Validation Needs/Requirements
Gamal Amer, Principal at Premier Compliance Services, Inc.
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This web-seminar will discuss Process Analytical Technology (PAT), which represents one of the new approaches used by the pharmaceutical industry to mitigate risk. Development of PAT is an extension of the FDA Guidance published in August 2002 and titled “Pharmaceutical CGMP for the 21st Century: A Risk-based Approach - A science and risk-based approach to product quality regulation incorporating an integrated quality system approach. We will explore what PAT means and its basic building blocks using the FDA guideline of September 2004. We will also review what its intended result is and its requirements and conditions are. We will also discuss some of the current applications in industry. Once we have developed this base, the presentation will pose questions and attempt to respond to them. The main questions to be discussed are: - How will validation as it is currently conducted be affected?
- Where and when does PAT start?
- What are the expected effects of applying PAT to pharmaceutical manufacturing?
- Who is the operator in this brave new world of PAT?
Tuesday, December 16th, 2008
11:00 AM EST
Beyond UV: Advanced Detection Technology in the LC Laboratory
Michael Swartz, PH.D., Research Director, Synomics Pharmaceutical Services
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Ultraviolet (UV) detectors are the workhorse in any laboratory using liquid chromatography (LC). However, there are many detectors in addition to UV that can provide a wealth of information, particularly since not every compound posses a UV chromophore. This presentation will address the use of LC detectors beyond the traditional single wavelength UV detector, e.g. photodiode array (PDA), evaporative light scattering (ELSD), fluorescence (FL), corona charged aerosol (CAD) and (briefly) mass spectrometry (MS) detectors; their properties and applicability. Examples of the use of advanced detection technology in a regulated environment will be addressed, along with the following topics: * Evaluating detector properties to determine the right fit for your application.
* Optimizing detector properties for a given task
* Challenges faced in fast LC and VHPLC.
* How advanced LC detectors compliment new chromatographic modes.
ARCHIVED WEBCASTS High Throughput in the LC-MS/MS Laboratory
Sponsored by Thermo Fisher Scientific
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Available through November 19, 2009 Looking Into the Lipidome: New Approaches to Analyzing Lipids
Sponsored by ESA Biosciences Inc.
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Available through November 5, 2009 From Analytical to Mass-Directed Purification
Sponsored By Thar Instruments
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Available through October 28, 2009 Automated Size and Shape Analysis of Sub-Micron Particles Using Electron Microscopy
Sponsored By FEI and Malvern Instruments
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Available through October 22, 2009 How a Single Detector Makes Complex HPLC Analyses Simple for a Wide Spectrum of Analytes: Ions, Surfactants, Polymers, Biofuel
Sponsored By ESA Biosciences Inc.
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Available through September 17, 2009 Recent Trends In The Development And Manufacturing Of Fusion Proteins As Therapeutics
Sponsored By Laureate Pharma
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Available through September 9, 2009 Quality Systems in a Global Market
Sponsored By SGS
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Available through June 12, 2009 Enhancing Tech Transfer from Development into cGMP Operations
Sponsored By Laureate Pharma
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Available through April 28, 2009 Beyond Theory: How to Implement Changes to USP Chapter <467> Residual Solvents
Tuesday, April 22, 2008
Sponsored by Celsis
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Available through April 22, 2009 |
For questions or more information please contact Jamie Carpenter at
jcarpenter@advanstar.com or call 800-234-4535 |
