Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production a..
Pivot Tables have been a mainstay of the Excel program for two decades, and yet they remain a daunting and little-understood tool. If you are a daily user of Excel, then at some point you will be faced with the challenge of the data analysis. The 1st level of that process is sorting and filtering. And the 2nd level is Pivot Tables. Without them, you will be spinning your wheels trying to make sense of data...
This webinar is focused on pacing delay, a controversial delay issue in the construction industry. Currently there is little literature on pacing delay and case law is a bit sparse. Thus, owners and contractors often find themselves at odds with one another over the practical effect of pacing delay in a delay claim situation. The webinar defines the term; identifies what constitutes pacing..
This seminar will provide an overview of water systems used for pharmaceutical manufacturing. We will cover validation, monitoring, and analyzing data results. What data collected means, how excursions should be handled, and what actions can be done if a problem does occur. What can be expected when the water system is audited by regulatory bodies or clients.This presentation provides an overview on the dif..
I will discuss four important parts of a business process (clinical study); you will gain from my description of common issues and misconceptions, their basis and remedy, and also through real live stories I provide with the four areas I discuss.Is your work well organized, according to the business process? Areas CoveredDefinitions of data, information, security, responsibility, and their meaning, wh..
In this fast-moving presentation, HR, engagement, and coaching expert, Don Phin, will share with you strategies and tools to help you and your managers step up their engagement and performance management games by learning how to coach their direct reports. Coaching helps for a myriad of reasons. The best managers and employees want to improve their ability to engage everyone from board members to the rank a..
This webinar will go in depth about everything you ever wanted to know about LLC classifications. We will first look at what being an LLC means and how the entity will file their tax returns. We will look at both foreign and domestic entities and how the check the box rules will vary based on if it is foreign or domestic. Lastly, we will look at the tax consequences of changing entity classifications.Areas ..
A table is a powerful feature to group your data together in Excel. Think of a table as a specific set of rows and columns in a spreadsheet. You can have multiple tables on the same sheet. You might think that your data in an Excel spreadsheet is already in a table simply because it's in rows and columns. However, your data isn't in a true "table" unless you've used the specific Excel data table feature.Are..
The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or ..
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. While these practices have been employed, companies are being forced to do more work with fewer resources, leading to errors ..
As managers or supervisors who are tasked with getting work done through others your communication style matters. The way to begin to communicate more effectively will depend greatly on your knowing more about your particular communication style, as well as your preferences for taking in information and your ability to filter the incorrect information from the correct. By learning how to effectively and app..
Becoming a new supervisor is an exciting step in your career. But chances are, the skills that got you promoted may not fully lay the groundwork for supervisory success. There are five categories of supervisory skills to focus on in order to accelerate your success as a supervisor. They are:People skills ("soft" skills) Setting expectations, managing performanceCommunicationPeople development, andTech..
Instrumental liquid chromatography, either as HPLC or UPLC, are a common technique in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, im..
Inside this course you will learn from Celebrity Trainer & CEO “Prof. Paul” who teaches the little-known secrets that top leaders use to rise above the rest. Top CEOs and team leaders use these tools to get impressive results now you can too. You deserve to have the best leadership skills available, leadership skills that are unique and can’t be found anywhere else. Inside this leadership course you wil..
The potential benefits of a biomarker in drug development are very significant. Careful identification of the context of use is necessary for the successful use of a biomarker. Biomarker use could benefit individual patients participating in clinical trials (e.g., earlier identification of toxicity with a safety biomarker) or general drug development and regulatory decision-making (e.g., a prognostic or pre..