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33842 Conferences

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What is Process Validation Report | 21CFR11 Compliance Checklist 2018

What is Process Validation Report | 21CFR11 Compliance Checklist 2018

Location: , Germany
Category: Education
Start Date: 01-11-2018 Last Day: 01-12-2018 Deadline for abstracts: 01-09-2018
Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and /…
What is Project Management in Pharmaceutical Industry Seminar

What is Project Management in Pharmaceutical Industry Seminar

Location: , United States
Category: Health and Medicine
Start Date: 01-15-2018 Last Day: 01-16-2018 Deadline for abstracts: 01-13-2018
Course "Risk Based Project Management for the Life Sciences Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Project management is a discipline that can be applied to all industries. In the pharmaceutical industry, project management is the key to addressing the unique regulatory, compliance and quality related needs of the industry. The process of clinical research and drug development, coupled with the critical issue of time to market, can use project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to…
Medical Device Software Risk Management Standard | Software Expert 2018

Medical Device Software Risk Management Standard | Software Expert 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-18-2018 Last Day: 01-19-2018 Deadline for abstracts: 01-16-2018
Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing…
Principal Investigator Responsibilities in Clinical Research | GCP 2018

Principal Investigator Responsibilities in Clinical Research | GCP 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-18-2018 Last Day: 01-19-2018 Deadline for abstracts: 01-16-2018
Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is known as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and, most…
FDA General Principles of Software Validation | Cyber Security 2018

FDA General Principles of Software Validation | Cyber Security 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-18-2018 Last Day: 01-19-2018 Deadline for abstracts: 01-16-2018
Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks…
What is the HIPAA Compliance | HIPAA Privacy Compliance Training 2018

What is the HIPAA Compliance | HIPAA Privacy Compliance Training 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-18-2018 Last Day: 01-19-2018 Deadline for abstracts: 01-16-2018
Overview: This two-day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop…
Verification vs. Validation - Product Process Software and QMS 2018

Verification vs. Validation - Product Process Software and QMS 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-22-2018 Last Day: 01-23-2018 Deadline for abstracts: 01-20-2018
Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course…
Complaints and Recalls | Complaint Handling System in Boston 2018

Complaints and Recalls | Complaint Handling System in Boston 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-25-2018 Last Day: 01-26-2018 Deadline for abstracts: 01-23-2018
Course "Complaint and Recall Management: A Compliant, Lean Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to…
21 CFR Part 11 Validation Checklist | Computer Systems Validation

21 CFR Part 11 Validation Checklist | Computer Systems Validation

Location: , United States
Category: Health and Medicine
Start Date: 01-25-2018 Last Day: 01-26-2018 Deadline for abstracts: 01-23-2018
Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and…
Internal Audit Checklist for Medical Devices | Quality Audit

Internal Audit Checklist for Medical Devices | Quality Audit

Location: , United States
Category: Education
Start Date: 01-25-2018 Last Day: 01-26-2018 Deadline for abstracts: 01-23-2018
Course "Quality Audits for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS. In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2ndparty) play a role in an effective supplier management program; your company could…
Product Reliability Training Courses | Product Reliability Testing

Product Reliability Training Courses | Product Reliability Testing

Location: , United States
Category: Education
Start Date: 01-29-2018 Last Day: 01-30-2018 Deadline for abstracts: 01-28-2018
Course "Predicting & Improving Product Reliability" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Although a primary objective of reliability analysis is to improve product reliability, there are many possible reasons for collecting and analyzing reliability data. Several examples are the following: Assessing product reliability in the field Predicting product warranty costs Estimate replacement part/spares requirements Assessing the effect of a proposed design change Demonstrating product reliability to customers or government agencies Comparing components from multiple suppliers Comparing components from…
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

Location: , United States
Category: Health and Medicine
Start Date: 01-29-2018 Last Day: 01-30-2018 Deadline for abstracts: 01-28-2018
Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a…

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