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...

This course is a basic/ fundamental level introduction and review of document control and related employee training for regulated industry. Key regulatory references will be included, but participants may need to consider additional product/ company/ geographic requirements. Why should you Attend: The failure to control documents and personnel training may indicate (to an auditor) that the quality system is not being well managed. If documents...

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why should you Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of y...

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation.You'll learn about what processes needed to be validated and what steps you need to take to validate processes. Why should you Attend: You’ll learn the benefits and impacts of validation and how it can benefit your customers and your business. We’ll cover tools and techniques that c...

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. Why should you Attend: All Laboratory and Quality Assurance management, analysts and reviewers should be aware of the FDA expectations for procedures that define a complete, scientifically s...

All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more. Why should you Attend: Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceuticals, chemicals and petrochemicals, and environmental analyses then yo...

OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. Why should you Attend: For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperles...

When the Directive 95/46/EC was adopted across all 28 EU Member States, it had effectively become obsolete as a result of changes in technology coupled with no mechanism for making the Directive future-proof. Why should you Attend: The webinar looks at the substantive differences between the previous Data Protection Directive 95/46/EC and the GDPR. There are many new features including a risk-based approach and sanctions/fines of up to 4% of g...

Stress-testing requires lateral knowledge and skills to be thoroughly pursued and constantly updated. It is no longer enough to neglect low-likelihood risks, even when there few or no past occurrences of these risks, and if the perspective looks far away. Areas Covered in the Session: Stress-testing and scenario analysis The regulatory view - before The regulatory view - after Why and how stress-testing Designing and developing scenarios Deriv...

The compliance date for the new rule is December 1, 2016. This 90-minute webinar will simplify what you need to do to overcome the complex process involves in calculating calories in restaurant meals. Why should you Attend: This webinar will highlight the in depth exploration of the new rules. You will learn how to make calorie and nutrient declarations using the principle of reasonable basis. Areas Covered in the Session: Overview of the Regu...