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ComplianceOnline

2479 East Bayshore Road
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94303 Palo Alto
United States
Phone : +88871 8887172436
Fax : +1 8887172436
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Themes :
Bio-Technologies, Pharmacy

Upcoming events


The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?

Réf: 28892 Tuesday February 19th, 2019 - Palo Alto US

EditorialThis training on OIG Self-Disclosure Protocol will help the attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting. It will also review the need for the organization to be aware of excluded ...

Conference & Seminar: Management, Management & Taxation, Hospital

EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

Réf: 28915 Tuesday February 19th, 2019 - Palo Alto US

Editorial This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the ...

Conference & Seminar: Management

Surviving an FDA Sponsor Inspection - Training for Success

Réf: 28921 Tuesday February 19th, 2019 - Palo Alto US

Editorial This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also ...

Conference & Seminar: Hospital, Management

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Réf: 28925 Wednesday February 20th, 2019 - Palo Alto US

Editorial This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a ...

Conference & Seminar: Management

Introduction to Root Cause Investigation for CAPA

Réf: 28930 Thursday February 21st, 2019 - Palo Alto US

Editorial This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation. Objectives If ...

Conference & Seminar: Management

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Réf: 29044 Thursday February 21st, 2019 - Palo Alto US

Editorial Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the ...

Conference & Seminar: Management

Nasal Decolonization as a Tool for Infection Prevention

Réf: 29045 Thursday February 21st, 2019 - Palo Alto US

Editorial This healthcare compliance webinar will focus on the risk of MRSA colonization to patients and others. Attendees will learn the current practice of nasal screening and isolation for MRSA colonized patients will be described as well as universal decolonization as an alternative will ...

Conference & Seminar: Public Health, National Health, Hospital

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Réf: 29047 Thursday February 21st, 2019 - Palo Alto US

Editorial This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic ...

Conference & Seminar: Management

Current Concepts and Challenges in Cloud Compliance

Réf: 29048 Thursday February 21st, 2019 - Palo Alto US

Editorial Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed ...

Conference & Seminar: Computer science

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Réf: 29113 Thursday February 21st, 2019 - Palo Alto US

Editorial This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory ...

Conference & Seminar: Management

Bundled Payment Review: How Case Management Can Play a Strategic Role

Réf: 29049 Friday February 22nd, 2019 - Palo Alto US

Editorial This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated across the continuum model. Objectives By attending this webinar, attendees will be able to become familiar ...

Conference & Seminar: Management

Project Management for Computer Systems Validation

Réf: 28931 Tuesday February 26th, 2019 - Palo Alto US

Editorial This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA ...

Conference & Seminar: Management

Establishing a Medical Device Security Program

Réf: 28932 Tuesday February 26th, 2019 - Palo Alto US

Editorial In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are ...

Conference & Seminar: Hospital

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Réf: 29050 Tuesday February 26th, 2019 - Palo Alto US

Editorial This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more. Objectives Attention and memory failures are usually associated ...

Conference & Seminar: Management

FDA Compliance and Clinical Trial Computer System Validation

Réf: 28936 Wednesday February 27th, 2019 - Palo Alto US

Editorial This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry ...

Conference & Seminar: Management

Medical Device Employee Training - Requirements and Implementation Tips

Réf: 29051 Wednesday February 27th, 2019 - Palo Alto US

Editorial This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness. Objectives Understanding FDA and ISO training requirements Understanding how to ...

Conference & Seminar: Management

505(b)(2) NDAs

Réf: 29052 Wednesday February 27th, 2019 - Palo Alto US

Editorial In this webinar attendees will learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship ...

Conference & Seminar: Hospital, Management

Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

Réf: 28847 Thursday February 28th, 2019 - Online

Editorial This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for ...

Conference & Seminar: Hospital

Prevention of Infection in Healthcare Workers

Réf: 28974 Thursday February 28th, 2019 - Palo Alto US

Editorial For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety ...

Conference & Seminar: Hospital

Prevention of Infection in Healthcare Workers

Réf: 29054 Thursday February 28th, 2019 - Palo Alto US

Editorial For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety ...

Conference & Seminar: Hospital

FDA Regulations for Environmental Monitoring (EM) Program

Réf: 28975 Monday March 04th, 2019 - Palo Alto US

Editorial This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four ...

Conference & Seminar: Hospital, Management & Taxation

Batch Record Review and Product Release

Réf: 28977 Tuesday March 05th, 2019 - Palo Alto US

Editorial In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents ...

Conference & Seminar: Management

How to Write Effective 483 and Warning Letter Responses

Réf: 28978 Tuesday March 05th, 2019 - Palo Alto US

Editorial In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the ...

Conference & Seminar: Management

Supplier and Service Provider Controls: FDA Expectations

Réf: 28937 Wednesday March 06th, 2019 - Palo Alto US

Editorial This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should ...

Conference & Seminar: Management

The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals

Réf: 23027 03/07/2019 -> 03/08/2019 - San Francisco US

Course Description: All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of ...

Conference & Seminar: Pharmacy

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