Industry: Biotechnology / Biopharmaceutical

Pharmaceutical Technology Transfer and Regulatory Strategies

This 12-hour accredited ON DEMAND course, will provide a basic understanding of the technology transfer of analytical methods, active pharmaceutical ingredients, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting transfers within and outside a company. Topics will include… Continue reading Pharmaceutical Technology Transfer and Regulatory Strategies

Writing and Enforcing Effective SOPs Basics

This 90-minute accredited training will address how to write effective Standard Operating Procedures in support of your company’s activities. You will learn how to organize and deliver information for the intended audience and purpose. You will learn how to write clear and readable documents, and how to revise and refine your own and others writing.… Continue reading Writing and Enforcing Effective SOPs Basics

Rheology and Surfactants: Chemistry, Theory, and Applicatio

The high surface tension of water presents challenges to a formulator who attempts to develop products that will properly wet surfaces, disperse pigments, emulsify key components, or even generate or destabilize foam. It is imperative that we understand how materials are affected, by their flow behavior, as a result of applied stress forces. This knowledge… Continue reading Rheology and Surfactants: Chemistry, Theory, and Applicatio

Effective Complaint Handling Procedures

This accredited 90-minute training will provide attendees with an understanding of the rules and regulations guiding complaint handling and complaint files within the life science industries. Per 21 CFR Part 820.198, Each manufacturer shall maintain complaint files, establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. While a product… Continue reading Effective Complaint Handling Procedures

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

Designing, Development, Drafting, Processing and Approval of An Effective and Compliant SOP or STM 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… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Selecting Raw Materials for Skin Product Development

Scientific discoveries about Epigenetics and Skin microbiome introduce new families of potential ingredients to the skin care industry. They can be paired with existing ingredients of proven efficacy to boost results. With so many cosmetic ingredients available today, selecting the right ones to include in a formulation can be quite challenging. Without adequate knowledge, the… Continue reading Selecting Raw Materials for Skin Product Development

Excipients: Compliance with Compendial and GMP Requirements

Excipients often play a critical role in the manufacture of bio/pharmaceuticals and in the formulation of small molecule and biotherapeutic products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States… Continue reading Excipients: Compliance with Compendial and GMP Requirements

Auditing Stability Programs: How to Ensure a Compliant Program

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: How to Ensure a Compliant Program

Cleaning Validation: Best Practices to Implement an Effective and Compliant Process

Cleaning Validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a… Continue reading Cleaning Validation: Best Practices to Implement an Effective and Compliant Process

Basic Principles of Cleaning Validation in the Pharmaceutical Industry

This 12-hour accredited ON DEMAND training course, will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling… Continue reading Basic Principles of Cleaning Validation in the Pharmaceutical Industry