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ComplianceOnline - visiting card : 46 results

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Medical meetings - Medical educations

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Medical meetings, medical seminar, medical education, medical symposium, medical CME, medical colloquy, medical training cycle, medical clinical, medical post graduate degree, medical good practice guide, medical conference.
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How to Investigate Environmental Monitoring Excursions

Ref: 30028 Tuesday September 17th, 2019 - Palo Alto US

Editorial This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. Program Medical products are manufactured in environments that control the level of ...

Conference & Seminar: Research, Management

How to Investigate Environmental Monitoring Excursions

Ref: 30262 Tuesday September 17th, 2019 - Palo Alto US

Editorial This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.   Objectives Medical products are manufactured in ...

Conference & Seminar: Research

How to Investigate Environmental Monitoring Excursions

Ref: 30325 Tuesday September 17th, 2019 - Palo Alto US

Editorial This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
  Objectives Medical products are manufactured in environments that control ...

Conference & Seminar: Hospital

Comparability Protocols For Approved Drugs

Ref: 30416 Tuesday September 17th, 2019 - Palo Alto US

Editorial This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, ...

Conference & Seminar: Pharmacy

Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae

Ref: 30027 Wednesday September 18th, 2019 - Palo Alto US

Editorial This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide ...

Conference & Seminar: Hospital, Management

Project Management for FDA-Regulated Companies

Ref: 30263 Wednesday September 18th, 2019 - Palo Alto US

Editorial This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management ...

Conference & Seminar: Management

Management of the Data Safety Management Committee for Clinical Trials

Ref: 30292 Wednesday September 18th, 2019 - Palo Alto US

Editorial Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.
  Objectives You will gain current, practical knowledge about the responsibilities, functions, and ...

Conference & Seminar: Management

3-hr Virtual Seminar: Coding Evaluation and Management Services to Survive an Audit

Ref: 30345 Wednesday September 18th, 2019 - Palo Alto US

Editorial This webinar will help physicians and non-physician practitioners document efficiently and to effectively support evaluation and management (E/M) codes to survive a payer audit.
  Objectives Payer audits are inevitable in today’s healthcare environment. Third-party payers ...

Conference & Seminar: Management

Project Management for FDA-Regulated Companies

Ref: 30364 Wednesday September 18th, 2019 - Palo Alto US

Editorial This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management ...

Conference & Seminar: Management

Technical Writing in an Industrial Environment

Ref: 30365 Thursday September 19th, 2019 - Palo Alto US

Editorial Attend this webinar to learn the logical, fast and simple process of how to easily write any document that your company requires. Explore how to organize collected information, write the document and address the comments from reviewers and approvers.
  Objectives Technical ...

Conference & Seminar: Management

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Ref: 30377 Thursday September 19th, 2019 - Palo Alto US

Editorial   In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly ...

Conference & Seminar: Management

How to Develop, Implement and Manage an Effective Change Control Program

Ref: 30378 Thursday September 19th, 2019 - Palo Alto US

Editorial This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control ...

Conference & Seminar: Management

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

Ref: 30327 Friday September 20th, 2019 - Palo Alto US

Editorial
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and ...

Conference & Seminar: Hospital

FDA's Ambitious Regulation of Social Media

Ref: 30264 Tuesday September 24th, 2019 - Palo Alto US

Editorial FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and ...

Conference & Seminar: Management & Taxation

FDA's Ambitious Regulation of Social Media

Ref: 30275 Tuesday September 24th, 2019 - Palo Alto US

Editorial FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and ...

Conference & Seminar: Management, Diet & Nutrition

The Regulation of in-house IVDs and accreditation of laboratory users in Australia

Ref: 30337 Wednesday September 25th, 2019 - Palo Alto US

Editorial Attend this webinar to understand the definitions of in-house IVDs, the regulatory requirements including classification & essential principles, the NATA requirements related to how and when IVDs can be used as a research or diagnostic tool and the current laboratory supervision ...

Conference & Seminar: Hospital

Regulatory Inspections - How to prepare for a visit from an FDA Auditor

Ref: 30379 Wednesday September 25th, 2019 - Palo Alto US

Editorial This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before ...

Conference & Seminar: Management

Understanding FDAs Governance of Prescription Drug Development: Manufacturing/cGMPs, Submission Process and Post Approval Commitments - ...

Ref: 30406 Wednesday September 25th, 2019 - Palo Alto US

Editorial In this webinar, we will review in detail major considerations to be well-thought-out during the prescription drug product development process. We will review in depth FDA cGMPs and their importance in drug manufacturing. We will review the submission process and post-approval ...

Conference & Seminar: Management

EU ISO 13485:2016 Medical Device Quality Management System

Ref: 30265 Wednesday October 02nd, 2019 - Palo Alto US

Editorial Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection ...

Conference & Seminar: Management

EU ISO 13485:2016 Medical Device Quality Management System

Ref: 30328 Wednesday October 02nd, 2019 - Palo Alto US

Editorial Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection expectations.
  Objectives In the U. S., the ...

Conference & Seminar: Management

Reducing memory and attention failures/errors: Understanding Cognitive Load

Ref: 30413 Wednesday October 02nd, 2019 - Palo Alto US

Editorial Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage and usually factors associated ...

Conference & Seminar: Pharmacy

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, ...

Ref: 30326 Tuesday October 08th, 2019 - Palo Alto US

Editorial This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device ...

Conference & Seminar: Management

Root Cause Analysis - The Heart of Corrective Action

Ref: 30329 Tuesday October 08th, 2019 - Palo Alto US

Editorial This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis. Objectives Reviewing CAPA The difference between Correction, Corrective Action and Preventive ...

Conference & Seminar: Management

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Ref: 30381 Tuesday October 08th, 2019 - Palo Alto US

Editorial This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the ...

Conference & Seminar: Pharmacy

Recognizing and Responding to "Red Flags" in Clinical Operations

Ref: 30418 Tuesday October 08th, 2019 - Palo Alto US

Editorial Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and ...

Conference & Seminar: Hospital

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