Industry: Biotechnology / Biopharmaceutical

Ensuring Your Supply Chain through Supplier Qualification

The Covid-19 pandemic demonstrated the importance of appropriately managing pharmaceutical and medical device supply chains. Weaknesses in the supply chain that were hidden or ignored resulted in production disruptions and in some cases product shortages. The foundation of supply chain management starts with Supplier Qualification. Supplier evaluation and qualification not only makes good business sense… Continue reading Ensuring Your Supply Chain through Supplier Qualification

GXP Foundations

GXP are a set of regulations and guidelines that together embody best practices for several key elements of medical product development. Because the regulatory landscape is complex and medical product innovations are both unique and diverse, it can be difficult for sponsors to develop a framework for product development and marketing that is both acceptable… Continue reading GXP Foundations

Effective Handling of cGMP Raw Materials

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is an integral and essential process that ensures drug product quality, purity and potency. Drug product manufacturers must have… Continue reading Effective Handling of cGMP Raw Materials

Designing an Effective Environmental Monitoring Program

Determining a Cleanroom State of Control The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training, and practices. It… Continue reading Designing an Effective Environmental Monitoring Program

BioPharmaceutical Analytics: Regulations and Validations

This 6 hour accredited ON DEMAND training will teach basic analytical regulations as they apply to method validations. This course, divided into four segments, will go through multiple bioanalytical methods and how to examine them for validation readiness and how to perform a validation. The methods in this course will include UV-VIS, SE-HPLC, HIC HPLC,… Continue reading BioPharmaceutical Analytics: Regulations and Validations

Laboratory Controls: Anticipate the Systems Based FDA Inspection

In this 90-minute accredited training, we will discuss laboratory controls. It will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA. Many QA and QC personnel… Continue reading Laboratory Controls: Anticipate the Systems Based FDA Inspection

Stability Operations for Drugs, Biologics and Medical Devices: Steps to a Successful Stability Function

This 12-hour accredited coursefocuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management. Preparing for inspections and… Continue reading Stability Operations for Drugs, Biologics and Medical Devices: Steps to a Successful Stability Function

Proper Batch Record Review for Compliance and Effectiveness

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that… Continue reading Proper Batch Record Review for Compliance and Effectiveness

An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies: How It All Comes Together

Before any new drug product is launched, it must first be shown through clinical studies that it is safe and effective. The cornerstone of these studies is the clinical supplies. Unless these supplies are prepared and labeled correctly, patient safety could be compromised and expensive clinical trials may be in jeopardy. The aim of this… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies: How It All Comes Together

Understanding the Process Validation Life Cycle

This 90-minute, accredited ON DEMAND training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological/pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic… Continue reading Understanding the Process Validation Life Cycle