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ComplianceOnline, OnlineEvent
2012-08-22
Why Should You Attend: This webinar is designed to provide an overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. We will discuss drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities and general impurities (not structurally related to the drug substance), such as residual solvents and elemental impurities. A comprehensive 7-hr training is available on the same topic. Please click here to view the areas covered in that training. Learning Objectives: At the end of this session, attendees will be able to: - Identify the various categories of impurities likely to be present in pharmaceutical products.
- Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each.
- Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form.
- Report the results of testing consistent with expectations of regulatory agencies.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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Deadline for Abstracts:
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2012-08-21
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Registration:
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| $299.00 | One Dial-in One Attendee |
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E-mail:
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referral@complianceonline.com
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