Subject: R&D

Effective Handling of cGMP Raw Materials

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is an integral and essential process that ensures drug product quality, purity and potency. Drug product manufacturers must have… Continue reading Effective Handling of cGMP Raw Materials

Sulfate-Free Surfactants

Personal care and cosmetic products heavily rely on surfactants for their properties and performance. However, there have been growing concerns about the use of sulfate-containing surfactants in cosmetics, and the reasons for this are not always transparent. To address these concerns, this 90-minute accredited training will delve into the issue and explore alternative surfactants and… Continue reading Sulfate-Free Surfactants

Laboratory Controls: Anticipate the Systems Based FDA Inspection

Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory. Because of this, it is important for lab… Continue reading Laboratory Controls: Anticipate the Systems Based FDA Inspection

Stability Operations for Drugs, Biologics and Medical Devices

This accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management. Preparing for inspections and… Continue reading Stability Operations for Drugs, Biologics and Medical Devices

Stability Testing for Protein Drug Products & Substances

No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program. This intensive course provides comprehensive and up-to-date knowledge of developing… Continue reading Stability Testing for Protein Drug Products & Substances

Effective Approach to Human Error Reduction

In GMP regulated industries, it is not enough to address human error deviations as an inconvenience; it is a regulatory requirement. The quality control unit is responsible for ensuring that errors are fully investigated and prevented as per the Code of Federal Regulations (21 CFR 211.22). However, human error is not a root cause but… Continue reading Effective Approach to Human Error Reduction

OTC Stability Program for FDA Compliance

In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. With the ICH guidance documents covering New Chemical Entities (NCEs) and their associated drug products, there was no guidance provided for OTC drugs covered by an ANDA or an OTC monograph.… Continue reading OTC Stability Program for FDA Compliance

HPLC (High Performance Liquid Chromatography): Basics – 101

HPLC is one of the most widely used and versatile analytical instruments in the laboratory today. Because of the many different modes of operation, it can be difficult for many to understand some of its complexities. But with proper training, HPLC can be the tool of choice for the analytical chemist. This HPLC course is… Continue reading HPLC (High Performance Liquid Chromatography): Basics – 101

Introduction to Modern Cosmetic Preservation

Preservatives are an essential component of consumer products, and basic knowledge of preservative technology is important for marketers and formulators. It is necessary to understand the nature of microorganisms and the mechanisms that disrupt their growth. Many traditional preservatives are formaldehyde donors. Parabens, which are excellent products, are the victims of bad publicity. Several non-traditional… Continue reading Introduction to Modern Cosmetic Preservation

Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems

“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” While a few of these situations may actually involve intentional fraud, others may occur where simply inadequate controls have been put into place to prevent data manipulation. Whether intentional or not, FDA views these situations as unacceptable.… Continue reading Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems