Listen to this program to understand what you can and cannot do with regard to Marketing to Medicare and Medicaid Beneficiaries. Register for the webinar today. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link - https://www.onlinecompliancepanel.com/webinar/Marketing-to-Medicare-or-Medicaid-Beneficiaries-What-You-Can-and-Cannot-Do-504719/FEBRUARY-2019-ES-TRAININGREGISTRY
Learn the best practices in implementing the OSHA VPP program. Register for this one hour webinar by Keith Warwick. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link - https://www.onlinecompliancepanel.com/webinar/OSHA-s-Voluntary-Protection-Program-504803/JANUARY-2019-ES-TRAININGREGISTRY
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.
Join this webinar to understand the new requirements for electronic injury and illness reporting, how to correctly fill out the OSHA 300, 301, and 300A logs, more. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link - https://www.onlinecompliancepanel.com/webinar/OSHA-s-E-Recordkeeping-and-Significant-Injury-Reporting-Rules-Updates-to-be-compliant-with-in-2019-506899/JANUARY-2019-ES-TRAININGREGISTRY
In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.
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.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
Healthcare professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many healthcare workers are putting in longer hours and for less pay.
From working twenty-four shifts to simply burning the midnight oil catching up on paperwork, the healthcare industry puts a great deal of stress and fatigue on the average worker and their relationships, including family.
Healthcare professionals bare witness to human suffering on a routine basis and are constantly reminded that tragedy, pain, and challenge often loom large in the midst of helping patients heal. As a result, compassion fatigue and burnout are major hazards of the profession that are becoming far too common.
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
The statistical methods discussed during the webinar include the following:
Process Control Charts
Process Capability Indices
Confidence / Reliability Calculations
MTBF Studies ("Mean Time Between Failures" of electronic equipment)
QC Sampling Plans
Root Cause Failure Analysis 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.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
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?
Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.
The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.
Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:
Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.
What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.
This session will cover various types of essential documentation, subject specific and non-subject specific, for clinical trials involving drugs, biologics and medical devices trials.
This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and loss.
To provide current concepts in seasonal influenza vaccines for the 2018-2019 season
To assess how strain matching and efficacy are linked.
What vaccines are available this season in USA and ROW.
Non egg adapted vaccines.
Trivalent and quadrivalent vaccines.
This years vaccine composition and WHO recommended strains.
Towards a universal Influenza vaccine.
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.
The logic of how various types of NIR equipment is designed and operated, how it obtains and generates spectra, how the software generates results and can control processes.
This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.
It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning including understanding insight vendor performance measurement including metrics and key performance indicators.