FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During...

Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this...

Each training day consists of eight full hours of instruction and skill practice. Trainee trainers must demonstrate competence at the end of the seminar by developing and...

Supplier Management for Medical Device Manufacturers Supplier selection and management is a fundamental issue faced by medical device manufacturers. Suppliers are critical to...

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21...

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is...

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21...

Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information,...

Why should you attend: Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on...

The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard...

This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life...

Regulation proposals of the European Commission Background In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a...

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal...

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process...

Bad Things Happen, But It Can Get Worse - Understanding FDA Post Market Regulations *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! You can participate...

Business Continuity Auditing Plans Using ISO 22301 This seminar will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss...

GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a...

Description eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The international agreement...

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The international agreement to assemble...

This course will discuss the four "problem children" that an auditor may encounter during an audit, and how to deal with Volatile Emotional Troublemaker Passive We will discuss...

What are the basic steps for implementing a project using Project Management methodology? What role will I have to play in implementation? What happens if I've never worked on a...

Description The 8th Genomics & Big Data Summit to be held on June 6-7, 2018 in San Diego, CA, has four focus areas to discuss the developments and challenges in the popular...

Description 4th Annual ComplianceOnline Medical Device Summit 2018 *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Key Attraction Innovate novel ideas...

4th Annual ComplianceOnline Medical Device Summit 2018 *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Key Attraction Innovate novel ideas for...

HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update...

FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During...

This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and...

A Risk Based Scientific Approach to Analytical Methods Development and Validation Activities for FDA Regulated Industries This Course introduces the schematics of Methods...

Biostatistics for the Non-Statistician Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next...

This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must...