Functional System Requirements for Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Defining the functional re..
Technical Writing: A Detailed Process
The webinar addresses the question of why we create technical documents. Indeed, why do Technical Writing at all? All members of organizations will be required to document something that we have done. The assignment may be to create a Standard Operating Procedure, a technical manual, a report, a test script, a job description, training documents or any of a myriad of things to be documented. This is the rol..
The Cost of Quality: How to Determine Financial Loss Through Sigma Scores
Cost Justification: What is Your Organization’s Sigma LevelSigma Level versus dollars lost as a percent of sales is explained. By understanding your processes sigma and addressing risk properly your organization will benefit considerably. Improvement Team Selection The success of quality improvement projects will come down to the quality of the team members working on the project. Responsibilities of P..
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..
Class Action Basics
This 60-minute webinar will provide an overview of class actions. We will discuss what a class action is and how it is different from other types of lawsuits. We will then discuss the class certification process and how the settlement is handled.Upon course completion, you will be able to:Describe what makes class actions specialUnderstand the class certification processDiscuss the requirements of:o Numeros..
10 Great Time Savers In Outlook 2013 And 2016
Do you use Outlook just for email or do you use it as the headquarters for your daily planning and execution of tasks? Whichever way you use Outlook, you will want to take advantage of the 10 in-depth tips outlined in this webinar that will make you more efficient and effective every day of your life. You’ll learn how to save precious minutes throughout the day, setting you free to use those minutes in prod..
Building Your Winning Team
First, we will discuss what sets a team apart from other forms of getting things done. Teams do certain things extremely well but they are not suited for all tasks. How to tell the difference and decide whether or not to use a team approach will be explored.Once you decide to build a team, how do you do it? The planning, criteria, and process of forming a team will be explained. Clearly defined goals, stand..
Human Error Reduction in GMP & Manufacturing Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..
Purchasing Procedures Implementation
For Existing Procurement Offices Review What Is Working and What Isn't Working in Your Current Environment...Ask Customers That You Service to Provide Feedback or a Formal Customer Satisfaction SurveyMeet With Current Stake Holders That Use Your Procurement Documents in their WorkflowMeet With Outside Control Agencies or Departments that Impact WorkflowBased on the Feedback Lay out an Implementation Plan th..
Due Diligence Steps for Form 1099 Compliance
Form 1099-MISC compliance is a surprisingly complicated compliance requirement for businesses and accountants. The requirements are always changing, and answers are seldom clear-cut. This course will de-mystify some of the tricky areas relating to Form 1099-MISC, such as when 1099 should be issued and whether a worker is a contractor or an employee. The main focus of this presentation is on “box 7” (indepen..
Elements of Effectively Coaching Employees
Coaching is a process of helping another individual realize their inner potential, delivering fulfilment to both the individual and the related organization. Coaching in the workplace typically focuses on an improvement in individual performance against key performance indicators or job expectations but can also focus on career development and employee growth. Unfortunately, coaching is the part of a manage..
SOPs for Commercialization
SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions, including sales, marketing, manufacturing, quality, and regulatory affairs. An absence of and non-adherence to SOPs are often cited in reg..
HACCP - How to Create a HACCP-Concept and How to Deal With CP's and CCP’s?
The HACCP methodology is risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintenance HACCP files documentation and find and define the checkpoints (CP) and critical checkpoints (CCP) in material flow from goods in control over the manufacturing steps until the final goods storage. Which is mandatory for phar..
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Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..
ICH Q10, The Pharmaceutical Quality System – Bring the Pharmaceutical Industry Into the 20st Century
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented thr..