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 webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Why should you Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector's inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can't understand them, and too many times we've seen procedures being constantly revised.
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.
In 2016, the ICH revised the E6 guidelines to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.
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
FinCEN has promulgated new rule for customer due diligence that is encouraging, in a very official way, to go beyond the check box mentality that has really plagued all KYC since the first Patriot Act was passed.
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/New-Customer-Due-Diligence-Rules-Are-you-Ready-508757/SEPTEMBER-2018-ES-TRAININGREGISTRY
This presentation will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.Price:$160.00. 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/Medical-Director-Contracting-Key-Pitfalls-to-Avoid-506752/SEPTEMBER-2018-ES-TRAININGREGISTRY
This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution. 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/Red-Flags-of-Money-Laundering-509031/SEPTEMBER-2018-ES-TRAININGREGISTRY
Join us for a study of best practices guidelines for payroll tax compliance. Learn the processes, controls and procedures to follow and keep your tax obligations paid on a timely basis. Learn the process for setting up new hires properly. Identify the steps to ensure all workers are properly classified as either employees or independent contractors and employees are properly classified as either FLSA exempt or nonexempt.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/Payroll-Legislative-Update-509757/SEPTEMBER-2018-ES-TRAININGREGISTRY
By attending this session you will be able to ensure that you understand the compliance issues directly related to the practice of case management and that you have incorporated them into your daily practice. Compliance includes documentation and communication with the patient and family as well. Be sure that your processes are hard-wired and part of your daily routine.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/Compliance-Measures-for-Case-Managers-508519/SEPTEMBER-2018-ES-TRAININGREGISTRY
This course is designed to provide CPAs who perform financial statement preparation, compilation or review engagements with the most current best practices and identify practice pitfalls. In addition, the course will cover the new SSARS No. 24. 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/2018-Financial-Statement-Preparation-Compilation-and-Review-506594/SEPTEMBER-2018-ES-TRAININGREGISTRY
This course will discuss procedures and processes your BSA department can employ when your institution is clearing and disposing alerts for potential hits identified by your screening process related to companies, individuals, and countries identified by government, international, internal, and other lists as sanctioned or of concern for money laundering, terrorist financing or other criminal activity. 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/Your-Sanctions-Program-and-How-to-Clear-True-Hits-and-False-Positives-509977/SEPTEMBER-2018-ES-TRAININGREGISTRY
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. 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/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY
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 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Compliance-with-the-CMS-Open-Payments-Rule-Sunshine-Act-504674/AUGUST-2018-ES-TRAININGREGISTRY
This training program will explore the vital world of advanced financial statement analysis. This session will include a review of the four financial statements and a five-step analysis model including liquidity, activity, leverage, operating performance, and cash flow. It will also review the Z-score (bankruptcy predictor) and the sustainable growth models. The webinar is a must for all commercial lenders and credit administrators.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/Advanced-Financial-Statement-Analysis-Liquidity-Activity-Leverage-Operating-Performance-Cash-Flow-Z-Score-and-Case-Studies-506503/AUGUST-2018-ES-TRAININGREGISTRY
The objective of this program is to provide lenders with a simple checklist that they can utilize whenever they receive a business' profit and loss statement information. At the end of this program, participants will be more comfortable with knowing what to pay attention to when they analyze the profit and loss statement of a business.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/Ten-Things-to-Look-For-When-Analyzing-Profit-and-Loss-Statements-509585/AUGUST-2018-ES-TRAININGREGISTRY