The webinar provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.
Why should you Attend:
It is important that a clean room's HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.
This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.
Areas Covered in the Session:
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software
This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations.
Why should you Attend:
A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.
We will discuss the pro's and con's of a implementing a zero incident workplace culture and describe how to determine if you are doing it right.
Why should you Attend:
A zero injury workplace safety cultures consist of shared beliefs, practices, and attitudes that exist within an organization. Culture is the atmosphere created by those beliefs, attitudes, etc., which shape our behavior.
This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents.
Why should you Attend:
This session will discuss comments from industry, health care providers, health care insurers and other concerned parties. The latest legal considerations, decisions and conclusions will be discussed as well as future expectations for off-label promotion of medical products.
Overview: That childhood ADHD predisposes to increased risks for impairment in educational, family, peer, and eventual occupational functioning by young adulthood, among many other major domains of life activities is well established in research. Less appreciated is that the disorder also predisposes to increased health, medical, and dental risks, such as an increased risk for accidental injuries across the lifespan. And ADHD also predisposes to certainly personality traits and lifestyle choices that have a significant impact on these health related factors.
Such risks and impairments are known to influence estimated life expectancy. This lecture describes the various domains of major life activities that have been found to be significantly impaired in children growing up with ADHD by their young adult years.
Overview: Practicing medicine is not like other jobs that have a tradition of retirement at age 65. Physician shortages fuel support for physicians seeking to continue their careers indefinitely. Patient safety is paramount, but is it served by applying an age limit to medical staff membership and clinical privileges?
If so, what is the magic number?
Why should you Attend: Can medical staffs and hospitals place restrictions on physicians based on age?
Should hospitals and medical staffs place restrictions on physicians based on age?
Can physicians sue, alleging discrimination and civil rights violations?
Areas Covered in the Session:
Age Restrictions on Medical Staff membership and clinical privileges
State Laws affecting physician age restrictions
Federal laws affecting physician age restrictions
Accreditation requirements related to age-based credentialing
Implementation of age-based screening
Eligibility for peer review protection
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.
This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
To begin, networking skills actually improve interpersonal communication skills with coworkers and supervisors. At the core, networking skills are about how to help people get to know you, like you, and trust you. These skills help ensure that every interaction you have with people leaves them happy that they interacted with you. You have the choice to be one of those people that people dread working with, or being the person that people request for their teams.
This webinar will provide a comprehensive review of FDA and Office for Human Research Protections (OHRP) reporting requirements for investigators. A comparison will be provided for the AE reporting requirements for drugs and devices.
In this webinar, we will explore the best approach to C-TPAT certification and discuss best practices, and The attendees will learn how to develop a standard approach to complying with the voluntary C-TPAT guidelines, and Strategies for reducing the cost and complexity of compliance with C-TPAT.
Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention on a world-wide basis. As the industry's utilization of risk-based monitoring continues to increase along with the development and expansion of the area of RBQM, the need for the integration of these two concepts becomes apparent.
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
Value Stream Mapping is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents, ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. In Addition to the Members of ICH (Us, Eu And Japan), Many Other Groups were involved in the Expert Working Committees that were involved in the Development of these Documents, Etc
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This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists
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Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be audited, had completed pre-audit questionnaires and knew the exact questions it would be asked and documentation to be provided (audit protocols).
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