Subject: Regulatory

Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible.… Continue reading Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Handling OOS Test Results and Completing Robust Investigations

It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations

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

Pharmaceutical Technology Transfer and Project Management

Gain a fundamental comprehension of technology transfer in the pharmaceutical industry, including the transfer of analytical methods, quality control standards, packaging components/operations, and various dosage forms from R&D to manufacturing. This course provides an overview of scale-up and technology transfer of solid dosage forms, injectables, and semisolids. During the course, we will delve into the… Continue reading Pharmaceutical Technology Transfer and Project Management

Auditing Stability Programs

A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and… Continue reading Auditing Stability Programs

Surfactants: A Greener and More Sustainable Approach

Surfactants play a vital role in many aspects of modern life and are widely used. This accredited training will describe the types of surfactants we use, how they are made and the environmental concerns over their use. It will discuss methods of making surfactants from natural products with a lower environmental impact. Unfortunately, a number… Continue reading Surfactants: A Greener and More Sustainable Approach

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

Data Integrity Practices for the Laboratory and Beyond

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory… Continue reading Data Integrity Practices for the Laboratory and Beyond

Cosmetic Claims Support Studies

As the cosmetic industry aims to create safer products and unique claims to stand out in the market, scientific resources need to prioritize testing products for their skin activity while meeting all product claims. Developing common criteria for justifying claims is a challenging aspect of product development, as it must be customized for the intended… Continue reading Cosmetic Claims Support Studies

IQ/OQ/PQ

The Installation/Operational/Performance Qualification (IQ/OQ/PQ) of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated, and maintained within design specifications and facilities must be accepted as fit… Continue reading IQ/OQ/PQ