On-Demand Webinar
Proof It! How To Be a Better Proofreader
Any document, media piece, or email bearing your organization’s insignia or name must be absolutely error free. Even a careless mistake in an email can damage a leader’s reputation and can make an entire company look bad. Proofreading is a skill anyone can learn and improve. Very few business professionals actually ever have been TAUGHT how to proofread. More and more employers are citing “attention t..
Proper Documentation and SOPs to Ensure Laboratory Compliance
This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is required for complianceWhat are typical citations as it relates to laboratory documentationWith forethought and design, good procedures are possible Good documentation and record integrity ensure good complianceA..
Proper Way to Terminate Employees with Performance Issues without Violating Title VII of the Civil Rights Act
Employers have always avoided the termination either because it is not easy to terminate someone or because it can be difficult to defend any allegations of wrongful termination. Cases of wrongful termination have emerged and increased since the late 2000 year. Research has identified the following factors in this increase: Employees more aware and knowledgeable of the workplace rightsEmplo..
Proving & Pricing Subcontractor Delay Claims
Much has been written over the years about proving and pricing contractor claims on construction projects. But little has been published about or presented on subcontractor delay claims. Do subcontractors have the same rights and remedies as the prime contractor? Are they held to the same standards? What are their legal rights? Do owners owe time extensions for subcontractor delays? Are prime contractors at..
Psychiatric Illnesses in the Workplace
More and more people –often your employees suffer from mental illness. Whether this is a result of the environment or better diagnostic tools is open to question. Those with a mental illness often deny this fact and often try to hide it from employers. Such is often a result of fear of being terminated or to avoid the stigma often attached to mental illness. As a result, mental health disorders often g..
Purchasing Controls and Receiving Acceptance for Medical Devices
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ ..
Putting Business and Analysis back in Business Analysis
Do you sense business analysis and business analysts are falling behind? Is it as fulfilling as you’d like or expect, and do others give it the respect it needs and deserves? For instance, increasingly business analysts seem left out of Agile projects. These all can be signals business analysis is failing to provide adequate business value. It may merely reflect difficulty communicating value that actually ..
QMS Quality Management System
Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees. The reason to have a QMS is not to satisfy the regulators, but for any employee to find the reason for doing the work they should do and how it is connected to the rest of the company.Any of you who wants to do a good job needs to know the reasons, rules, and ..
Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience
CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry. The control of changes is one such topic that is complex. Lessons from practical experience show methods that will prevent a development program from becoming uncompli..
Qualification of Suppliers and Contract Manufacturing Organizations
Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppl..
Quality Agreements For Contract Manufacturing Operations
It is important for contract manufacturing operations, whether they are in the cosmetic, drug, or device industries to have a Quality Agreement in place. This webinar will teach you what a Quality Agreement is, why you need a Quality Agreement, where and when Quality Agreements are needed, and who should prepare, review, and approve a Quality Agreement.Areas CoveredWhat is a Quality Agreement?What should be..
Quality Control for Analytical Materials used in Microbiology Laboratories
Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements but also to meet the requirements of ISO/IEC 17025. During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits, and reagents specifically app..
Quality Risk Management Overview
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 ofte..
Quality System Management Effectiveness
Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. A good QMS consists of standards and guidelines relating to their everyday business practices including but not limited to policies/procedures (or a Quality Manual), SOPs, and Work Instructions.It’s the common, centralized culture of quality that many people struggle wi..
Ratios the Road to Improve Profits & Productivity
All business professionals need a good working knowledge of financial statements to include how they are created and how they can be used to make key business decisions. Business/financial transactions are transformed into financial statements through an accounting process.Three required statements are produced:Income StatementBalance SheetCash Flow StatementThe statements provide Results of business activi..