This webinar discusses global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to life-cycle of the product manufacturing process. Establishing of health-based Cleaning Validation limits also discussed in ..
Manufacturing in Mexico as a maquiladora under the IMMEX program (formally known as the Maquiladora Program) can offer tremendous benefits for virtually any foreign manufacturer, especially those selling into the North American market. Established in 1965 by the Mexican government as a way to reduce unemployment along the borders, the maquiladora program offers foreign companies easy access to inexpensive l..
Today, much work in organizations is organized as a project although it may not be called a project. Often, through years of downsizing, people with in-depth special knowledge in critical areas are no longer available. The work still needs to be performed when needed, so someone is assigned. Thinking about these special, periodic assignments as projects and applying the approaches of project management help..
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..
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..
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..
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..
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..
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 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..
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..
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..
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 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..