Subject: GMP

Analytical Methods Validation – 21CFR211.165(e)

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process… Continue reading Analytical Methods Validation – 21CFR211.165(e)

Writing and Enforcing Effective SOPs Basics

The purpose of this accredited training is to equip participants with the necessary skills for writing effective Standard Operating Procedures (SOPs) that support their company’s activities. Throughout the course, participants will learn how to organize and deliver information tailored to the intended audience and purpose, write documents that are clear and easy to read, and… Continue reading Writing and Enforcing Effective SOPs Basics

Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Navigating the Stability Universe

There is a universe of individuals, departments, and contract organizations outside the direct control of the Stabilitarian which interact with the stability process in ways that can boost or hinder the success of the program. Some of these are obvious while others go virtually unrecognized, yet members of both can impact us severely and deserve… Continue reading Navigating the Stability Universe

Effective and Compliant Technical Writing

This technical writing training program will offer you an understanding of how the reporting process supports products in research, development, and in the marketplace. This training will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train you on effectively reviewing… Continue reading Effective and Compliant Technical Writing

Excipients: Compliance with Compendial and GMP Requirements

Excipients are crucial in the manufacturing and formulation of bio/pharmaceuticals, enabling medicines to be delivered to patients in need. Compliance with appropriate quality and regulatory requirements is essential for companies that manufacture, distribute, and use excipients. The United States Pharmacopeia-National Formulary (USP-NF) requires that official substances be prepared according to recognized principles of good manufacturing… Continue reading Excipients: Compliance with Compendial and GMP Requirements

Ensuring Your Supply Chain through Supplier Qualification

The Covid-19 pandemic highlighted the significance of effectively managing pharmaceutical and medical device supply chains. Previously hidden or overlooked vulnerabilities in the supply chain led to production disruptions and, in some cases, product shortages. To ensure regulatory compliance and sound business practices, supplier qualification is the foundation of effective supply chain management for pharmaceuticals and… Continue reading Ensuring Your Supply Chain through Supplier Qualification

GXP Foundations

GXP represents a collection of regulations and guidelines that encompass best practices for various crucial aspects of medical product development. Due to the intricate regulatory environment and the distinctiveness and diversity of medical product innovations, it can be challenging for sponsors to establish a framework for product development and marketing that satisfies regulatory requirements while… Continue reading GXP Foundations

Spray Drying: Advanced Technology Overview

This accredited course focuses on Spray-Drying technology, a very important process in numerous industries. The course will emphasize the scientific fundamentals and practical operational aspects of Spray-Drying that are seen day-to-day in industries such as Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc. The primary goal will be to help scientists, engineers, and operations professionals… Continue reading Spray Drying: Advanced Technology Overview

An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies

Clinical studies are essential to ensuring the safety and effectiveness of new drug products before they are launched. The cornerstone of these studies is the clinical supplies, which must be properly labeled and prepared to ensure patient safety as well as prevent expensive clinical trial delays. To provide a high-level overview and introduction to the… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies