Subject: Compliance

GMPs for Dietary Supplements

This course will benefit all professionals involved with the manufacture, supply, testing, holding or distribution of dietary supplements whether they be the owner, vendor, manufacturer, or consultant. Individuals from the following areas will particularly benefit from this course: – Quality Control/Assurance – Regulatory Affairs – Laboratory Operations – Auditing of in-house and contract laboratories –… Continue reading GMPs for Dietary Supplements

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]

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

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)

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

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 Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Managing Effective Regulatory Inspections and 483 Responses

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 Managing Effective Regulatory Inspections and 483 Responses

Computer System Validation: A Regulatory Overview

The ever-increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer-controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers,… Continue reading Computer System Validation: A Regulatory Overview

Navigating Digital Marketing and Clinical Claims in the Cosmetic Industry

Digital Content Rules for Clinical Claims and Brand Success The rules and regulations regarding supporting advertising claims for cosmetics have not changed. A claim cannot represent a cosmetic as a drug; the basis for claim support still needs to be consumer perceptible. However, the new vectors for sales and marketing via social media and website… Continue reading Navigating Digital Marketing and Clinical Claims in the Cosmetic Industry

Tacical Auditing: Tools and Techniques for a Better Audit Approach

Many organizations conduct quality audits because they are required to do so by their company or a regulatory agency. Others conduct the audits because they have been a good check for compliance to the regulatory standards. While all these reasons have varying degrees of validity, none of them articulate the best reason for having a… Continue reading Tacical Auditing: Tools and Techniques for a Better Audit Approach

Successful FDA Inspections: Essential Preparation and Management Tools

Regulatory inspections should demonstrate that your company is operating according to proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate the ways in which your quality systems assure this state of control. The arrival of a Regulatory Investigator can be a daunting experience. In… Continue reading Successful FDA Inspections: Essential Preparation and Management Tools