Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Why should you Attend:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.
Why should you Attend: We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.
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.
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
If the information can reach a consumer,FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers. Websites, chat rooms, op-ed articles or even your own postings in social media can cause your product to be misbranded, i.e., illegal.
These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Why should you Attend:
Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis. Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers.
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.
In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time.
HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive.
Legal compliance can get confusing when some legal regulations seemingly overlap or even seem almost contradictory to implement. This is the case when the Americans with Disabilities Act (ADA), the Family and Medical Leave Act (FMLA), and Workers’ Compensation intersect.
The intersecting of these three laws is complicated and open to problems if not handled correctly. ADA, FMLA and Workers Compensation have different goals and protections for employees, yet all three have provisions that may require an employer to give job-protected time off when the right circumstances are met.
When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
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.
By attending this webinar Participants will gain awareness of key signs and symptoms of compassion fatigue and burnout, while learning how to manage stressors and their consequences, This webinar focuses on understanding each of these challenges, their similarities and differences.
In this webinar John is conducting an online training session that will provide you with the proven strategies you need to stay out HIPAA hot water, HIPAA Compliance: Avoid Text/Email Danger Zones - you will be surprised by what can land you in serious trouble, This electronic communication can simplify life and complicate your HIPAA compliance.