A contractor's right to complete work early was acknowledged by U.S. Courts in the 1940's. As a result, delayed early completion claims became much more common in the 1960's. It was then, and remains now, a controversial issue in the construction industry with many project owners refusing to accept early completion baseline schedules. Others crafted contractual mechanisms prevent or defeat such claims.
This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.
Why should you Attend:
Case Study Examples will be provided for each session to further assist the attendees in understanding how to decide when to submit a 510(k) for a change to an existing device.
Training management is often focused only on aligning standard operating procedures with job titles, and tracking whether employees have been "trained" to the latest versions. But, quality standards and regulations actually focus on employee competence and awareness of their impact on quality.
This webinar will help attendees to better understand the actual intent of the standards and regulations, how to better establish requirements for each employee, and how to confirm that employees are truly competent.
Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions and corrective actions on duly manner.
This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities.
The two most common questions employers have are:
Our company does drug screenings, and an employee has provided a medical marijuana card. How do we handle that?
Our state allows recreational marijuana. What does this mean if we have a drug-free workplace policy?
The answers to these questions involve numerous factors, including but not limited to the following.
The state they are in
Why somebody is using it (medicinally or recreationally)
How recently they used it
The safety aspects of their job
The company's policy on marijuana use
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
This webinar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.
Attend this 90 minutes presentation to gain a fundamental understanding of
FDA's regulation of Dietary Supplements, Dietary supplements are regulated products, also Dietary supplement marketing, manufacturing, labeling, and advertising are all covered by regulations enforced by FDA.
Why should you Attend:
There is confusion in the industry as just what type of manufacturing
controls and record keeping, and labeling content is required by the FDA,
and this confusion continues to cause regulatory problems for many new
and established companies in this industry.
In this webinar speaker will explain how to choose the tests to be conducted
and the studies that must be completed prior to the actual validation test.
Why should you Attend:
We will explain how to choose the tests to be conducted and the studies
that must be completed prior to the actual validation test. The post test
participant inquiry is critical to validation success. we will describe how to do this.
There are challenges in dealing with people who bring toxicity to the interaction. One challenge is managing the impact it has on us - the other challenge is how to respond effectively - in essence - in ways that continue to allow us to get the job done and maintain a working relationship.
In this webinar, you will learn key strategies, tactics and skills to protect your emotional and psychological well-being, while at the same time not letting the other person control or dominate.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done.
The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolving for most efficient strategic planning.
Why should you Attend:
This webinar will give you a snap shot of what is current, what is coming and what this means to anyone who is currently developing Drugs and other Health Products for the Canadian market. The focus will be on drugs, biologics and medical devices.
Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.
Also, contamination during processing is a pathway for loss of sterility with a detrimental impact on shelf life. Stability programs for large molecule therapeutics require careful consideration of the factors that can lead to a negative impact on identity, potency, and sterility.
GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance.
The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Why you should attend
It is not possible to present a complete treatment of project management in the span of 6-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
This course is organized into three sections: The life cycle of a claim, coding systems, and reimbursement.
Life cycle of a claim
Many people understand a portion of the claim adjudication process, but they may not have a complete understanding of all steps necessary to generate and adjudicate claims. We walk through the entire life cycle of a medical claim, from patient registration through provision of services, from claim generation to adjudication, from payment to posting. This is useful for anyone new to the healthcare industry or for persons who want a more complete understanding of the entire claim life cycle.
This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. This includes how to properly validate an FDA-regulated computer system in order to ensure security and data integrity objectives are met.
Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.
Employers are getting it - sort of. Most believe in the concept of keeping their employees healthy because it just makes sense.
Not only does paying attention to this make a difference in the lives of the people who are the most valuable asset to a company, but there are also many benefits to the bottom line - lowered health claims, improved energy and morale, lowered sickness, and improved productivity.
Typical wellness programs may include conducting an annual health fair, inviting a speaker to do the odd lunch n' learn, or even providing gym or fitness subsidies. These initiatives are certainly good starting points, but are they worked into the overall objectives of the organization? Will companies really get the biggest bang for their buck? A one-size fits all program/lunch n' learn/health fair will not have the same effect or return.
Why should you Attend:
This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines. Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program.
This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.
Why should you Attend: Areas of Enterprise Risk Management include: business continuity, disaster recovery, cyber security, information security, emergency management and crisis management. If you are responsible for one of the enterprise risk areas and are not ensuring that the company is compliant, you may be held liable by your corporation.