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Liste des formations Management : 13 résultats

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GLP Comparison with GMP in Quality System -2017

Réf: 25874 Mercredi 04 Octobre 2017 - En ligne

Overview: Good Laboratory Practice (GLP) is a quality system which intend for non-clinical studies and was revised by several bodies. GLP is a unique quality system in the sense it is intend for non-routine processes and activities.   Why should you Attend: The authorities often ...

Formation: Médecine, Pharmacie, Management

What are Standards for Medical Device Software -2017

Réf: 25875 Mardi 10 Octobre 2017 - En ligne

Overview:   With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.   Why should you Attend: Why do all these documents exist, ...

Formation: Pharmacie, Médecine, Bio-Technologies, Informatique, Management

Laboratory Have an Instrument Calibration Program -2017

Réf: 25876 Mardi 10 Octobre 2017 - En ligne

Overview: This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument  classifications.   Why should you Attend: In this webinar ...

Formation: Pharmacie, Médecine, Bio-Technologies, Informatique, Management

Compliance for Computer Systems Regulated by FDA - 2017

Réf: 25877 Mardi 10 Octobre 2017 - En ligne

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 ...

Formation: Dentaire, Pharmacie, Médecine, Bio-Technologies, Informatique, Management

Cybersecurity and Computer Systems Validation - 2017

Réf: 25878 Mercredi 11 Octobre 2017 - En ligne

Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.   Why ...

Formation: Médecine, Pharmacie, Bio-Technologies, Management

Batch Record Review and Product Release - 2017

Réf: 25879 Vendredi 13 Octobre 2017 - En ligne

Overview: A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.   Why should you Attend:  Recognize regulatory ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Medical Device Engineering Change Control - 2017

Réf: 25880 Mardi 17 Octobre 2017 - En ligne

Overview:   This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be  compliant but not cumbersome or overly time consuming. The difference between pre release and post release ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Analytical Instrument Qualification and Validation Processes - 2017

Réf: 25881 Mardi 17 Octobre 2017 - En ligne

Overview:   In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

How to Develop the Risk Management File - 2017

Réf: 25882 Mercredi 18 Octobre 2017 - En ligne

Overview: The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer. ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

483 Covers a Broad Gradation of Problems

Réf: 25883 Mercredi 25 Octobre 2017 - En ligne

Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

NIST Cybersecurity Framework For Computer Systems Validation

Réf: 25884 Mercredi 25 Octobre 2017 - En ligne

Overview:   Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.  ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Guidance on Software and Device Changes and the 510(k)

Réf: 25885 Lundi 30 Octobre 2017 - En ligne

Overview:   The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.   Why should you Attend: Anyone who is involved in software and device design, ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management

Top 100+ Healthcare webinars You Can Get for $10

Réf: 25836 15/08/2017 -> 31/12/2018 - En ligne

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each. Regulatory compliance learning, that ...

Formation: Pharmacie, Bio-Technologies, Informatique, Management