Industry: Preclinical / Non-Clinical

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

Basic FDA GLP Training (Good Laboratory Practice Training)

No drug makes it into human usage without having first been demonstrated safe in animal models. Good Laboratory Practices (GLPs), which grew out of a lack of quality and scientific integrity in toxicology studies conducted in the 1970s, established FDA’s requirements for the conduct of such nonclinical studies. Bioanalytical analyses for GCP-regulated studies are also… Continue reading Basic FDA GLP Training (Good Laboratory Practice Training)

The 49th Amendment: IFRA Code of Practice

An Introduction to Fragrance Safety for the 21st Century The 49th Amendment to the IFRA Code of Practice introduces radical changes to the science behind fragrance safety and impacts the documentation of every fragrance in use. This 90-minute accredited ON DEMAND training course will describe the importance of the new fragrance safety guidelines. This course… Continue reading The 49th Amendment: IFRA Code of Practice

An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies: How It All Comes Together

Before any new drug product is launched, it must first be shown through clinical studies that it is safe and effective. The cornerstone of these studies is the clinical supplies. Unless these supplies are prepared and labeled correctly, patient safety could be compromised and expensive clinical trials may be in jeopardy. The aim of this… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies: How It All Comes Together

GLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges

Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn This intensive 8- hour accredited course has been entirely redesigned with Franklin’s cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to run regulatory studies that… Continue reading GLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges

GLP and Quality Assurance: Developing a GLP Compliant QA Program

Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories… Continue reading GLP and Quality Assurance: Developing a GLP Compliant QA Program

Good Laboratory Practices (GLP)

Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about Good Laboratory Practice (GLP) Regulations. Overall, the main intent of… Continue reading Good Laboratory Practices (GLP)

Qualification and Management of CMOs (Contract Manufacturing Organizations)

Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, examines… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)