Overview: You will learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file. Why should you Attend:...

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...

CONNECTIONS, will take place May 21-23, 2021 in San Francisco and will focus on technology solutions and strategies to expand the connected home ecosystem and drive consumer...

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...

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...

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...

Overview: Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for...

Description 4th Annual ComplianceOnline Medical Device Summit 2021 *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Key Attraction Innovate novel ideas...

4th Annual ComplianceOnline Medical Device Summit 2021 *** 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...

Description The 8th Genomics & Big Data Summit to be held on June 6-7, 2021 in San Diego, CA, has four focus areas to discuss the developments and challenges in the popular...

Overview: Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from...

Overview: This 60-min webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept 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...

On behalf of the organizing committee and global organizations, we take this opportunity to extend a warm welcome to all of you to participate at the 2nd Annual Conference on...

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based...

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan Global Medical Device...

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation The European Medicines Agency's (EMA) Guideline on good pharmacovigilance...

Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions...