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Liste des conférences et séminaires Management : 28 résultats

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Introduction to Root Cause Investigation for CAPA

Réf: 28930 Jeudi 21 Février 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 ...

Conférence & Séminaire: Management

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Réf: 29044 Jeudi 21 Février 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 ...

Conférence & Séminaire: Management

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Réf: 29047 Jeudi 21 Février 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 ...

Conférence & Séminaire: Management

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Réf: 29113 Jeudi 21 Février 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 ...

Conférence & Séminaire: Management

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

Réf: 29049 Vendredi 22 Février 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 ...

Conférence & Séminaire: Management

Project Management for Computer Systems Validation

Réf: 28931 Mardi 26 Février 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 ...

Conférence & Séminaire: Management

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

Réf: 29050 Mardi 26 Février 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 ...

Conférence & Séminaire: Management

FDA Compliance and Clinical Trial Computer System Validation

Réf: 28936 Mercredi 27 Février 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 ...

Conférence & Séminaire: Management

Medical Device Employee Training - Requirements and Implementation Tips

Réf: 29051 Mercredi 27 Février 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 ...

Conférence & Séminaire: Management

505(b)(2) NDAs

Réf: 29052 Mercredi 27 Février 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 ...

Conférence & Séminaire: Hôpital, Management

Batch Record Review and Product Release

Réf: 28977 Mardi 05 Mars 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 ...

Conférence & Séminaire: Management

How to Write Effective 483 and Warning Letter Responses

Réf: 28978 Mardi 05 Mars 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 ...

Conférence & Séminaire: Management

Supplier and Service Provider Controls: FDA Expectations

Réf: 28937 Mercredi 06 Mars 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 ...

Conférence & Séminaire: Management

Live Webinar on Mobile Medical Apps ( Is It an FDA Regulated Device? ) and Cyber-Security

Réf: 29030 Mercredi 06 Mars 2019 - En ligne

Learn how to meet the FDA software validation requirements and FDA cybersecurity requirements for your mobile medical apps. Also know how to get your mobile apps approved by FDA.

Conférence & Séminaire: Pharmacie, Management

Failure Modes and Effects Analysis - An effective Risk Management Tool

Réf: 28938 Jeudi 07 Mars 2019 - Palo Alto US

Editorial This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. Objectives FMEA (Failure Mode ...

Conférence & Séminaire: Management

Engaging Hospitalists in the Case Management Process

Réf: 28979 Jeudi 07 Mars 2019 - Palo Alto US

Editorial In this healthcare compliance webinar attendees will understand the role of the hospitalist, the hospitalist group and the collaboration responsibility with the case management department to ensure compliance with federal regulations, decreasing length of stay, and methods to improve ...

Conférence & Séminaire: Management

The Most Serious FDA 483s - How to Avoid Them

Réf: 28981 Mardi 12 Mars 2019 - Palo Alto US

Editorial This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.  Objectives Recent FDA audits ...

Conférence & Séminaire: Management

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

Réf: 28982 Mardi 12 Mars 2019 - Palo Alto US

Editorial This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines ...

Conférence & Séminaire: Management

FDA Regulations for Marketing OTC Drugs in the U.S.

Réf: 28983 Jeudi 14 Mars 2019 - Palo Alto US

Editorial This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S. Objectives Understanding U.S. FDA regulations and the OTC monograph system and its labeling requirements will help companies assure ...

Conférence & Séminaire: Management

Integrating Case Management Across the Continuum of Care: Managing Cost and Length of Stay

Réf: 28984 Lundi 18 Mars 2019 - Palo Alto US

Editorial In this webinar you will learn how to integrate case management across the continuum in reducing your hospital’s cost and length of stay. You will learn how to coordinate the patient’s transition between healthcare systems and settings such as moving from the hospital to ...

Conférence & Séminaire: Management

CDISC Mapping 2: ODM, MindMaps and References

Réf: 29053 Mercredi 27 Mars 2019 - Chicago US

Editorial This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure ...

Conférence & Séminaire: Management, Hôpital

21st Asia Pacific Diabetes Conference

Réf: 27997 28/03/2019 -> 29/03/2019 - Osaka JP

Share your research work with us and explore novel approaches in fields of Diabetes and Endocrinology and Meet leading Diabetes, Endocrinology, Obesity & Insulin therapy Professionals from Academia and industry from Australia, Japan, Korea, UAE, Saudi Arabia, Italy, Germany, and USA to take part

Conférence & Séminaire: Anatomie pat. & histo, Cardiologie, Diabète, Diététique & Nutrition, Endocrinologie, Médecine générale, Médecine interne, Management, Médecines naturelles, Pharmacie

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

Réf: 28985 Mardi 02 Avril 2019 - Palo Alto US

Editorial This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, ...

Conférence & Séminaire: Management, Hôpital

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

Réf: 28939 Jeudi 11 Avril 2019 - Palo Alto US

Editorial This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices. Program Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the ...

Conférence & Séminaire: Hôpital, Management

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