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CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
Implementing the New Lease Accounting Standards
In this webinar, you will learn practical tips for complying with the new guidelines for this complex area of accounting and reporting.Upon course completion, you will be able to analyze typical transactions to recognize their lease characteristics and account for and report them in compliance with the new rules.Since FAS #13 was released in November of 1976, lease accounting has been very stable in the USA..
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 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..
Mastering Chart And Graph Essentials In Excel 2013 to 2016
With 16 chart types in MS Excel including the new funnel chart, there are many choices to present information in a clear, engaging and professional manner.Each chart type has up to 7 sub-chart variations plus a massive range of formatting options and variations.Maximize your use of this powerful Excel feature and take data analysis and interpretation to an effective and appealing level, helping your audienc..
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 fulfillment 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 manag..
How to Identify And Complete A Successful Credit Union Merger or Bank Acquisition
Serving as senior management in a bank or credit union, on the board of directors of an institution, or serve these two industries this seminar is for you because, at some point in your career, you are very likely to be involved in a merger and acquisition transaction. Because of the increased regulatory burden imposed on banks and credit unions today, the struggle to replace retiring senior leaders w..
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..