Pharmacology - Drug Development
Listings
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The Veterinary Drug Approval Process and FDA Regulatory Oversight
Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisherThe U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process f...
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Essentials Of USP Microbiology
Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisherThe objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are use...
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Designing and Sustaining New and Existing Product Stability Testing Program
Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisherNew or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, som...
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Investigation of Out-of-Specification Test Results
Pharmacology - Drug Development san Jose (california) June 26, 2021 Check with publisherAttendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations. Responsibility of the Analyst Responsibility of the Supervisor Obvious error Retesting Resampling Result validation Initiation of a p...
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Human Error Reduction in GMP Manufacturing
Pharmacology - Drug Development san Jose (california) June 25, 2021 Check with publisherHuman error is known to be the major cause of observations from regulatory agencies, quality deviations, and production losses in many organizations. Although it is unlikely that human error will ever be totally eliminated, many human performance pro...
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Writing and Revising SOPs for Increased Operational Efficiency
Pharmacology - Drug Development san Jose (california) May 24, 2021 Check with publisherAre new staff confused during training on your SOPs? Do you have too many SOPs? Do some SOPs give directions that conflict with directions from other SOPs? Are you writing up deviations far too often? Do you have some SOPs that just plainly don’t mak...
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The Drug Development Process from Concept to Market
Pharmacology - Drug Development san Jose (california) May 22, 2021 Check with publisherThis course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeut...
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Data Integrity: FDA/EMA Requirements and Implementation
Pharmacology - Drug Development san Jose (california) May 22, 2021 Check with publisherThe integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pha...
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Process Validation Guidance Requirements (FDA and EU Annex 15
Pharmacology - Drug Development san Jose (california) May 15, 2021 Check with publisherThe Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manu...
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Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
Pharmacology - Drug Development san Jose (california) May 15, 2021 Check with publisherToday, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a...
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How to write SOP's that Avoid Human Error
Pharmacology - Drug Development san Jose (california) May 13, 2021 Check with publisherHuman error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design sta...
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CDOCKER Tutorial
Pharmacology - Drug Development (United States ) May 11, 2021 Check with publisherCDOCKER is a molecular docking method based on CHARMm's position, which can produce highly accurate docking results. CD ComputaBio provides detailed tutorial process for CDOCKER. Learn more at https://www.computabio.com/cdocker-tutorial.html.
