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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..
Regulatory Affairs Project Management
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on projec..
Regulatory Compliance for Deposits
Regulators have become even more focused to ensure financial institutions are operating with the consumer in mind. This has been an area of focus during examinations over the last few years.Understanding the regulatory compliance for deposits is important for anyone dealing in bank compliance. During this webinar, we will explore consumer compliance regulations for deposits in our current regulatory climate..
Reignite Recruiting: 9 Ways to Incorporate Diversity Strategies at Work
The demographics of the workforce are changing and companies are struggling to keep up with the challenges that can be caused by ignoring this elephant in the room. Are you an employer of choice? If not, why not? From reputation management to recruiting to employee engagement, this workshop will help you identify the many areas in which your decision-making process is unintentionally impacted by bias, as we..
Resolving Workplace Conflict
Whether people sit and work side by side or have to collaborate from thousands of miles away, there will be misunderstandings, hurt feelings and conflict. In this course we are going to explore some of the multiple reasons for conflict and look at appropriate interventions and solutions to solve them. Some conflict is simple to resolve, just some understanding of the impact your behaviour has on other. Othe..
Respect in the Workplace
In today's diverse workplace is a reflection of North American society at large. Often we see a wide range of behaviours that display a lack of respect and politeness, both inside and outside the workplace. Various polls and studies have highlighted that workers view impoliteness as a serious issue which must be dealt with. As the workforce becomes even more diverse than it is now, it is important that each..