Subject: QA/QC

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

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

Cosmetic Claims Support Studies

This course is intended for professionals in the cosmetic, pharmaceutical skin care, and personal care industries. It will be especially beneficial to those in the following fields: -Formulations -Regulatory Affairs -Clinical Testing -Product Design -Development Marketing

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

HPLC (High Performance Liquid Chromatography): Method Development

This HPLC course will benefit the personnel with some HPLC experience who are developing or optimizing HPLC methods. This 90- minute accredited course will include discussions of the theory of Reversed and Normal Phase, Ion Pairing, and Ion-Exchange Methods. It will also give basic starting points on method development and method evaluation of these methods.… Continue reading HPLC (High Performance Liquid Chromatography): Method Development

HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins

This 90-minute accredited ON DEMAND course will include discussions of the theory of SEC, Reversed Phase, Ion-Exchange, Hydrophobic Interaction, and Protein Affinity Chromatography. It will also give basic starting points on method development and method evaluation of these methods. The course is designed to give personnel with some HPLC experience a broader scope for how… Continue reading HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins

Introduction to Validation Principles, Practices and Requirements

FDA regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This 12-hour, accredited ON DEMAND course provides an overview and introduction to Validation principles and requirements. Discussed in this program are: -Process validation -Computer System Validation -Cleaning validation -Methods… Continue reading Introduction to Validation Principles, Practices and Requirements

Setting up and Implementing Supplier Audits

Every pharmaceutical, medical device or related industry company must rely on the dependability of their suppliers to consistently provide quality materials and services. Key to this is the establishment up front of a supplier quality agreement. But even once created and agreed upon, periodic audits are necessary to ensure it is being routinely followed. The… Continue reading Setting up and Implementing Supplier Audits

Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?

In its role mandated by the FD&C Act, FDA periodically performs site inspections to ensure that Pharmaceutical and Medical Device companies are in compliance with current Good Manufacturing Practices (cGMPs). The goal of these inspections is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.… Continue reading Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?

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