Consequences Web-based Seminars

Learning to work as a Team This team buiding training course teaches students how to be effective team members. Students learn how to communicate effectively, adapt to various personality styles, overcome common problems, work on aspects of verbal and nonverbal communication, create a supportive team environment, understand the source of team conflict, and employ different conflict resolution styles. Course activities also  more...

Business Ethics Training ...ess to solve ethical dilemmas, understanding barriers and consequences when making ethical decisions, and the process for blowing the whistle when unethical situations arise. Course activities also cover identifying common managerial ethical issues, being proactive with ethical issues, addressing subordinates ' ethical issues, identifying causes of unethical behavior, recognizing unethical  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...g distinctly different meanings with distinctly different consequences, are often incorrectly interchanged especialy efficiency and productivity. This 1-hour FREE webinar will address these three terms, demonstrate how to calculate each and describe where they are used in a manufacturing enterprise. With the demonstration of the formulas, we will explain how values derived from the formulas  more...

Verification vs Validation in Regulated Industries - webinars by gcp Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...tify employees of recourse systems, clarify expectations, consequences and rewards, reduce misunderstandings, save time and convey desired culture and behavior. Why you should attend: Human Resources policy is an important communication tool which can In Human Resources and as a manager, you will find yourself referring to the policies on a frequent basis and It is essential that Human  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...gnize their significance to their job and be aware of the consequences of non-compliance. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...called for by HIPAA and PCI. They will learn what are the consequences of not protecting health and payment information and what to do if their information security is compromised. We'll talk about strategies to limit exposures under PCI and HIPAA, and what steps can be taken to help limit the scope of compliance for PCI by keeping payment card information off of your office networks. Attendees  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...fference in shape and the problems it causes o Consequences of moving from Z1. 4 to c=0 + Inventory management and stock-outs * Supplier management and performance metrics Who Will Benefit: This seminar is designed for people in manufacturing who are involved in setting product specifications, setting up acceptance plans, performing acceptance activities, and  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...gnize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. Why you should attend: The Learning Objectives of this presentation include: * Discover what the regulations say  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...ility that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible for large plaintiffs' verdicts in products liability cases that arise from the off-label uses of their products. The pharmaceutical industry has been distributing reprints of scientific and journal articles on off-label uses of drugs for many  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...would be reasonably likely to have serious adverse health consequences, and if that device was either a permanently implantable device or a life-sustaining or life-supporting device used outside a device user facility. Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...mendment. There are differences in actions, reporting and consequences of deviations and violations and these will be discussed. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. TO not follow the protocol is folly. Why Should You Attend: Protocol Deviations and Violations are one of the most  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...gnize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the applicable US and EU expectations of documentation plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. According to the FDA, if it isn't written down, it didn't happen. As well, if it isna ™t  more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ...ility that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and  more...