Technical Tuesday: GAMP5 V2

31 January 2023 - 31 January 2023
Technical Tuesday: GAMP5 V2 31 Jan 2023 5.30-6.30pm SGT | Online Synopsis: Extensive experience in the validation process of most common Computerised Systems used in the Life Science environment (e.g. MES, LIMS, Lab Systems, DCS, QMS, PCS) according...
APQ

APQ Guide: Cultural Excellence

Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in quality culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data, assuring transparent problem escalation, and striving for operational excellence.
Artificial Intelligence Used to Optimize Fluid Bed Drying
Online Exclusives
Artificial Intelligence Used to Optimize Fluid Bed Drying

This article shows how non-supervised artificial intelligence (AI) methods can strongly support common processes in the pharmaceutical industry such as wet granulation drying. The techniques used demonstrate how continuous process optimization can be enabled and the process control strategy is permanently updated while keeping product quality under strong assurance and also increasing energy...

GMP Fundamentals: History

GMP Fundamentals: History

After a history of tragic events that affected public safety, the current Good Manufacturing Practices (GMPs) were developed. GMPs are a set of regulations that uphold the Federal Food, Drug, and Cosmetic Act. It is important to look back at the history of these events, their effect on public health...
GMP Fundamentals: Organization and Personnel

GMP Fundamentals: Organization and Personnel

The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the...
GMP Fundamentals: Quality System

GMP Fundamentals: Quality System

To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work...
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Produtos Biofarmacêuticos: Webinar de Introdução a Grandes Moléculas

Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Introdução a Grandes Moléculas Visão geral Este webinar é uma gravação do novo curso ministrado por instrutores que introduz os participantes ao desenvolvimento de biofármacos e abordará conceitos que destacam as diferenças entre...

Student Plant Tour: Jefferson Institute of Biotechnology GLP Processing Learning Space

8 December 2022 - 8 December 2022
Please join us at Jefferson Institute of Biotechnology (JIB) on December 8, 2022, where JIB students will be offering industry professionals a tour of their bioprocessing lab/learning space. This is a tremendous opportunity for students and industry...
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