Subject: QA/QC

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

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

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

Stability Testing for Protein Drug Products & Substances

No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program. This accredited 12-hour intensive course provides comprehensive and up-to-date knowledge… Continue reading Stability Testing for Protein Drug Products & Substances

Effective Approach to Human Error Reduction

Investigations, Root Cause Determination and CAPA Effectiveness If you work in a GMP regulated industry you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The Code of Federal Regulations (21 CFR 211.22) charge the quality control unit with the… Continue reading Effective Approach to Human Error Reduction

cGMP for Personal Care, Cosmetic and OTC Products

With public trust of drug manufacturers being challenged, the importance of following GMPs has never been more important. GMP compliance is not only a regulatory requirement, but a business necessity! This 12-hour intensive ON DEMAND course will provide an in-depth overview of Current Good Manufacturing Practices for personal care, cosmetic and OTC products and will… Continue reading cGMP for Personal Care, Cosmetic and OTC Products