Subject: QA/QC

An Introduction to Current Good Tissue Practice (GTP)

This course is intended for anyone who works for registered human cell, tissue, and cellular and tissue-based product (HCT/Ps) establishments which must comply with CGTP regulations. It is especially valuable to: – Executive Directors and CEOs – Recovery Personnel – Compliance Professionals – MDs and Medical Directors – Quality Assurance Managers and Personnel – Legal… Continue reading An Introduction to Current Good Tissue Practice (GTP)

Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

How to Meet Legal, Regulatory, and Compendial Requirements Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry.… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

Sunscreen Basics: From Theory to Practice

In the Cosmetic and Personal care market almost every day cream claims to offer a sun protection factor or SPF, and body products for summer holidays claim high SPF numbers. In the U.S. the sun-filters (UV absorbing molecules) are listed on a positive list, they are considered drugs which can be sold over the counter… Continue reading Sunscreen Basics: From Theory to Practice

INCI: International Nomenclature of Cosmetic Ingredients

In 1973 The Cosmetic, Toiletry, Fragrance Association (CTFA) developed an industry voluntary process for assigning ingredient names that provides the consumer and medical field a common approach to understanding what is formulated in a personal care product. This process was accepted by the United States Food & Drug Administration (FDA) and the global regulatory community,… Continue reading INCI: International Nomenclature of Cosmetic Ingredients

Microbiology for the Non-Microbiologist

Appropriate as a GMP Microbiological Refresher With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished product, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of… Continue reading Microbiology for the Non-Microbiologist

Formulating and Developing Contemporary Cosmetics

This course is intended for professionals from the following: Industries: – Cosmetics and Beauty Products Development and Manufacturing – Raw Materials Manufacturing and Supplying – Education, Science, and Research Departments: – Research &Development – Product Development and Marketing – Microbiology – Quality – Manufacturing Job Titles: Chemists; R&D Managers; Marketing Coordinators; Marketing Managers; Product Development… Continue reading Formulating and Developing Contemporary Cosmetics

Management of Pharmaceutical Water in a GMP Environment

This 90-minute course is intended for all scientists and technologists interested in developing a basic understanding or refresher of the basics of microbiology and the ramifications of non-compliance. The material will be presented in such a way as to be a value to a varying level of expertise. This course will especially benefit those in:… Continue reading Management of Pharmaceutical Water in a GMP Environment

Data Integrity

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Data Integrity

Complaint Handling Requirements (US)

Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities. The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard.… Continue reading Complaint Handling Requirements (US)

Best Practices for Investigation Deviations and Non-Conformances

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Best Practices for Investigation Deviations and Non-Conformances