Why Should You Attend:
Manufacturers of new drug products are required to comply with the new elemental impurities standards either thorough risk assessments or through testing as new regulatory submissions are made, whereas manufacturers of existing products while making decisions regarding the extent of risk assessment and testing required need to demonstrate compliance with the new standards. If the manufacturer's compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry).
The objective of this live training webinar 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.
Areas Covered in the Webinar:
Who Will Benefit:
Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.
In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.
He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing 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 is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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