Subject: R&D

IQ, OQ and PQ for the Laboratory

The FDA’s 21 CFR Part 211.160 establishes the legal requirement for calibrating laboratory equipment. Now more commonly referred to as Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), the qualification of equipment in a GMP Laboratory in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process and ongoing commercial batch release. Data… Continue reading IQ, OQ and PQ for the Laboratory

Dry Blending Technology

Dry blending is a key process in many industries. It is very important to understand the bulk solid properties that are present in an operation and how this affects process effectiveness. A lack of understanding can lead to excessive downtime and unnecessary expense to accompany. Several key areas will be covered including bulk solids properties,… Continue reading Dry Blending Technology

Competitive Intelligence in Product Development

Consider any successful product or service, and it is highly likely its benefits and differentiation were informed by competitive intelligence. Without it, the product or service may fail and soon disappear from the shelf. Competitive intelligence can literally make that much of a difference. This training course will introduce the discipline of competitive intelligence and… Continue reading Competitive Intelligence in Product Development

Designing and Testing Performance of Effervescent Products

Effervescent tablets have been used as products in the pharmaceutical and dietary industries for over two centuries. Rising demand for maintaining a healthier lifestyle is primarily responsible for driving the global effervescent products market. This is mainly due to the fact that effervescent products form a key ingredient of various dietary supplements, probiotics, and other… Continue reading Designing and Testing Performance of Effervescent Products

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

Smarter Stabilization Strategies in Cosmetic Formulation

Stabilization mechanisms are a major area of importance in cosmetic product development. Emulsions can be particularly challenging to address. This accredited ON DEMAND webinar will enable the participant to understand how emulsions fall apart, how to fix them, and how to do a better job in emulsion formulation design. In addition, the participant will learn… Continue reading Smarter Stabilization Strategies in Cosmetic Formulation

Packaging Design

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 accredited training, you will understand the range… Continue reading Packaging Design

Laboratory Controls Overview & Establishment of Specifications

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Consistent with current Good Manufacturing… Continue reading Laboratory Controls Overview & Establishment of Specifications

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)