Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However, integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often..
Whether people sit and work side by side or have to collaborate from thousands of miles away, there will be misunderstandings, hurt feelings and conflict. In this course we are going to explore some of the multiple reasons for conflict and look at appropriate interventions and solutions to solve them. Some conflict is simple to resolve, just some understanding of the impact your behaviour has on other. Othe..
Once an employee punches in, it is not just the start of their day – but also the start of an employer’s review for wage & hour compliance. Non-exempt or hourly employees are subject to and required to be given different meal breaks, rest periods, and compensation for things like travel time. This webinar gives employers the rules and regulations that need to be followed and also offers tips and techniq..
Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of R&D owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s expectations are ..
Creating procedures can be daunting, especially if you’ve never done it before. How do you know how to write something that other employees can follow? What belongs in policy versus a procedure? Is there an easy format to use for writing procedures?All these questions and more will be answered. You’ll be able to state with confidence that procedures are in place and be able to use them.Learning ObjectivesUn..
Many people feel overwhelmed when faced with the daunting task of documenting their company’s Sarbanes-Oxley controls. This presentation will help you to confidently deliver SOX documentation which auditors and executives are pleased to sign. The SOX documentation process does not have to be complicated. This presentation will show you how simple it can be.Documentation is simply writing down what it is tha..
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..
According to the US Dept of Labor, the new Exempt/Non-Exempt worker rules will result in the following:Workers directly affected. 4.2 million salaried workers will be affected by this rule based on their salaries. These workers are currently ineligible for overtime. The Department estimates that most of them (4.1 million) will become eligible for overtime when they work more than 40 hours (i.e., they will b..
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage, and handling procedures, and other variable are common and can lead to different results. Making each operation..
Communication is a two-way process to exchange ideas. We communicate in order to elicit some type of response. Some examples of a response could be more knowledge, a specific action, or some type of emotion.Understanding the D.I.S.C. profile will help understand the four different personality type and how they like to receive information. Do you have a clear understanding of how to communicate with others? ..