The first is the ability to design the organization to match the intended or desired outcomes, and second, the ability to recognize when the initial direction of the organization is different from the desired outcome and follow the necessary steps to correct this mismatch. Organizations that are able to do this are exemplary.
This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.
Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.
Travel pay computations can be complex and confusing, even for experienced payroll professionals. The FLSA and state wage and hour laws require employers to pay employees for all hours worked and include all hours worked in computing overtime compensation. An employee's total hours include all time spent doing work for the employer including time spent traveling on behalf of the employer.
In this webinar expert speaker, Patrick Haggerty will discuss what employers must know, which hours must be compensated, which payments must be included in the regular rate of pay, and how to compute the correct amount of overtime compensation.
In this session, industry veteran James G. Zack, Jr., will discuss impact damages and what they may include. You will gain a better understanding of impact damages and the issues surrounding this form of damages. This session will also explore 10 types of impact damage claims. For each of the 10 types of impact damage claims, Zack, Jr. will identify and discuss one or more potential defenses owners may employ to analyze and resolve impact damage issues.
Understand the best practices for the preparation of Corporate Board of Directors and Board Committee meeting minutes. Register for the webinar today.
Price:$199.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Corporate-Board-Meeting-Written-Records-and-Best-Practices-507518/JULY-2019-ES-TRAININGREGISTRY
Learn to determine what why and how of non conformances occurring in the laboratory. Register now.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Root-Cause-Analysis-RCA-in-the-Laboratory-Addressing-Non-Conformances-509217/JULY-2019-ES-TRAININGREGISTRY
Learn to utilise the features of Power Pivot and Query to summarise large amounts of data and streamline the process of presenting the results. Register now.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Supercharge-your-Excel-BI-Reporting-with-Power-Pivot-and-Power-Query-509835/JULY-2019-ES-TRAININGREGISTRY
You will learn how to identify and analyse toxic impurities in drug products from active pharmaceutical ingredients.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Toxic-Impurities-in-Active-Pharmaceutical-Ingredients-506938/JULY-2019-ES-TRAININGREGISTRY
Learn 21 CFR subpart J of FDA regulations related to CAPA, how to integrate CAPA with other branches of QMS. Register today for this webinar.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/CAPA-Simplified-A-One-Form-Easy-To-Complete-Method-for-Simplifying-Your-CAPA-Process-505214/JULY-2019-ES-TRAININGREGISTRY
This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Red-Flags-of-Money-Laundering-506645/JULY-2019-ES-TRAININGREGISTRY
Learn how to process and comply with different types of garnishment orders and what you need to know to avoid penalties.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Complying-with-Garnishment-Orders-What-Payroll-Professionals-Need-to-Know-in-2019-507536/JULY-2019-ES-TRAININGREGISTRY
Learn the best practices on how to make use of lubricants in food environment and the new food safety plan as well.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Guidance-for-Lubricant-Use-in-Food-Applications-505735/JULY-2019-ES-TRAININGREGISTRY
In this webinar we will explain in detail the process of conducting a hazard analysis and how to integrate hazard analysis into the design program. Join today.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Hazard-Analysis-Following-ISO-14971-509891/JULY-2019-ES-TRAININGREGISTRY
Attend this webinar to learn how to prepare for an FDA inspection, process of the inspection, roles assigned for these inspections and more.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -
https://www.onlinecompliancepanel.com/webinar/Best-Practices-for-Preparation-for-Behavior-during-and-Response-to-an-FDA-Inspection-502816/JULY-2019-ES-TRAININGREGISTRY
Explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -https://www.onlinecompliancepanel.com/webinar/Preventing-Human-Error-in-the-Life-Sciences-509812/JULY-2019-ES-TRAININGREGISTRY
Overview:
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Overview:
This is an introduction to software validation for medical device development targeted to software developers, engineers, testers and managers. It covers simple and small projects to mid-size projects including development projects and manufacturing projects. It will be useful for new hires in any of these functions and for persons assigned to audit the validation results.
Why should you Attend: There are several key elements that need to be included in your instrument Validation and Verification efforts to ensure compliance with FDA and EU IVDR (In-Vitro Diagnostics Regulation). The new regulations have added many new requirements that translate to new deliverables your testing report must provide.
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance.
This function is often given to outside consultants that may not understand your organization and try to fit you into a cookie cutter vendor model.
You need to really understand that this is more than a form or checklist. Otherwise you may be missing great opportunities to add value and de-risk your organization.