Subject: Manufacturing

Requirements of Aseptic Processing and Filtration Sterilization

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements of Aseptic Processing and Filtration Sterilization

Packakaging Design: Designing a Package to Maximize Product Impact

A package can mean the difference between proper dosing or failure to follow a drug regimen. It can build product loyalty or drive a user to switch to a different offering. It can also mean profitable manufacturing or a cost of goods headache. At the conclusion of this 90-minute accredited training, you will understand the… Continue reading Packakaging Design: Designing a Package to Maximize Product Impact

Basics of Microbiology

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Microbiology

Requirements for Aseptic Techniques and Practices

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements for Aseptic Techniques and Practices

Mixing Technology – Fundamentals and Applications

Experts in the field have developed this 90-minute training which presents mixing fundamentals and their application to a selection of commercial operations, considering the most recent developments in research and practice. The lectures will cover the basics of turbulence, emulsions, rheology and interfacial phenomena. Building on these basic concepts, mixing processes will be analyzed for… Continue reading Mixing Technology – Fundamentals and Applications

Cosmetic Ingredients: From Science to Practical Use

This 12-hour, accredited ON DEMAND training is intended to provide a practical utilization of cosmetic ingredients to build the best formula, meeting pre-established objectives and expected outcome. We will explore: – Relationship of structure-function-application-benefits – Practical understanding of classes of cosmetic ingredient and their key benefits and applications – Generation of a better understanding of… Continue reading Cosmetic Ingredients: From Science to Practical Use

Cleanroom, Microbiology and Sterility Assurance Practices

This intensive, 12- Hour course provides attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations, and industry practices. Key elements of sterility assurance and contamination control starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices

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

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

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