Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Why you should attend: Today's headlines are filled with instances of cyber attacks resulting in denial of service, data theft or compromise and even ransomware holding critica...

With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard. Why should you Attend: Why do all these documents exist, and how do they affect the work your group is doing on your company's software? What does a software group need to know about them, and what changes can we expect in the near future?...

This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications. Why should you Attend: In this webinar we will discuss instrument classification, getting the instrument into the calibration program, removing the instrument from the calibration program, instrument classification, limits...

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This Webinar will help you unde...

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. Why should you Attend: Recognize regulatory requirements for batch records and batch record review. Discover the essentials of batch record reviewer qualifications and training.Establish a working relationship between production a...

Good Laboratory Practice (GLP) is a quality system which intend for non-clinical studies and was revised by several bodies. GLP is a unique quality system in the sense it is intend for non-routine processes and activities. Why should you Attend: The authorities often required a GLP declaration and statement for submitted studies. Come to hear more on the requirements and particularly if you moving from another quality system like GMP or ISO 17...

This webinar will help you understand the various interpretations. We will discuss concepts for creating a culture of quality and management excellence with your company. Why should you Attend: Every organization has stakeholders. Your customers demand safe and effective medical devices. The regulators expect you to follow the regulations for your markets with resulting product quality and compliance. And your business can't survive without ef...

If you've been frustrated by other limitations of pivot tables then Power Pivot is for you. Simply put, Power Pivot takes pivot tables and data analysis to the next level. If you're a fan of pivot tables, you'll love Power Pivot. Areas Covered in the Session: Importing data into Excel from external sources Creating pivot tables from multiple sources Creating relationships and data models Introduction to DAX formulas Cleaning and transforming d...

Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. Areas Covered in the Session: GxP training requirements in US and EU Most frequently cited deviations Developing an effective training program for a company, site or department Developing a training plan for individual employees Who can or...

This analysis, using appropriate statistical methodology, under §820.100, identifies the cause of nonconforming products and other quality problems. The presentation also covers some special cases including data smoothing using moving averages, analysis with a lag function, and statistical process control (SPC). Why should you Attend: Data analysis can be difficult, especially when the appropriate method is not clear. This presentation ex...