We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations
I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!
In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).
Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for software enabled Medical Devices. Enroll for the webinar today.
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/IEC-62304-for-Medical-Device-Software-502216/JANUARY-2019-ES-TRAININGREGISTRY
Get an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry. This course will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.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/Tobacco-Industry-Trends-for-Computer-Systems-Regulated-by-FDA-508423/JANUARY-2019-ES-TRAININGREGISTRY
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Discover the increasing risks, obligations, and steep fines facing organizations who gather and process personal data from individuals in the U.S. and the European Economic Area (EEA).*
The GDPR went into effect on the 25 of May 2018; applicable to the 28 Member-States, plus members of the EEA - the GDPR also affects U.S.-based companies that transfer personal data from the EEA to the States.
This webinar will help you ensure an efficient and effective CAPA 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 webinar is for you.
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.
From there, the data subjected to the process of data management is repeatedly inspected to ensure that the data that finally appear in the report are identical to the original, i.e. nothing untoward has happened on the way.
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:
How to link risk with the confidence statements associated with the sampling plans
Identify a variety of sampling plans, that all make the desired confidence statements
Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
This 60-min webinar will familiarize participants with USP Chapter 1029 on good documentation guidelines, And This session will wrap up the general concept and will provide information as to what needs to be documented in certain records, Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
In this webinar we will explain in detail the process of conducting a hazard analysis, We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program, Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing.
The CMS Open Payments Rule (sometimes referred to as the "Physician Payment Sunshine Act") was born out of the Affordable Care Act. This presentation will walk you through the requirements under the regulation and discuss the logistics and strategies for compliance.
Price:$200.00. 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/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
Learn how to write SOP and work instructions and explore the true purpose and function of compliance documents. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Applying-Global-Standards-to-Life-Sciences-Compliance-Documentation-504874/AUGUST-2018-ES-TRAININGREGISTRY
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
Price:$250.00. 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/Effective-Records-Management-Document-Control-for-Medical-Devices-505756/AUGUST-2018-ES-TRAININGREGISTRY
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.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/The-FDA-Inspection-Process-From-SOP-to-483-506420/AUGUST-2018-ES-TRAININGREGISTRY
FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense.
The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these organizations. The specification developer must be aware of the capabilities of the contract manufacturer and the contract manufacturer must be aware of the limitations of the specification developer, for example.
FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.