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Liste des conférences et séminaires Management : 32 résultats

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Conférence et séminaire Management

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Good Documentation Guideline (Chapter <1029> USP)

Réf: 30382 Jeudi 24 Octobre 2019 - Palo Alto US

Editorial This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
  Objectives Good Documentation ...

Conférence & Séminaire: Management

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Réf: 30703 Mardi 05 Novembre 2019 - Palo Alto US

Editorial This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
  Objectives This webinar describes exactly what is required for ...

Conférence & Séminaire: Management

Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

Réf: 30707 Jeudi 07 Novembre 2019 - Palo Alto US

Editorial Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and ...

Conférence & Séminaire: Management

Aseptic Processing Overview and Validation

Réf: 30708 Lundi 11 Novembre 2019 - Palo Alto US

Editorial This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Objectives At the completion of this course, attendees will be able to: Explain the ...

Conférence & Séminaire: Management

How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

Réf: 30709 Mardi 12 Novembre 2019 - Palo Alto US

Editorial This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
  Objectives This webinar will ...

Conférence & Séminaire: Management

Writing and Revising SOPs for Increased Operational Efficiency

Réf: 30711 Mardi 12 Novembre 2019 - Palo Alto US

Editorial This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
  Objectives What is an SOP? Ways to structure systems of SOPs Examples of sections to include in an ...

Conférence & Séminaire: Management

Conducting Successful FDA Meetings

Réf: 30712 Vendredi 15 Novembre 2019 - Palo Alto US

Editorial If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. Knowing what makes FDA employees the way they are, will help immensely in understanding how to deal with FDA.
  Objectives Become familiar the types of jobs within FDA ...

Conférence & Séminaire: Management

7th Annual Congress on Dental Medicine and Orthodontics

Réf: 28806 18/11/2019 -> 19/11/2019 - Indonesia ID

Dental Conferences, Dentists congress, Dental implant conferences, Emergency Dental Care events, Endodontic and Orthodontic conferences, Oral health events, Oral Surgery meetings, Clinical Dentistry Conferences, Dental care Congress, Bali 2019

Conférence & Séminaire: Orthodontie, Dentisterie esthétique, Endodontie, Implantologie, Chirurgie orale, Parodontie, Prothèse, Prophylaxie, Occlusodontie, Management

How to Prepare a Standard Operating Procedure (SOP)?

Réf: 30383 Mardi 19 Novembre 2019 - Palo Alto US

Editorial This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
  Objectives Standard Operating Procedures ...

Conférence & Séminaire: Management

How to Prepare a Standard Operating Procedure (SOP)?

Réf: 30713 Mardi 19 Novembre 2019 - Palo Alto US

Editorial This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time. Objectives Record compliance with examples What ...

Conférence & Séminaire: Management

Best Practices for an Effective Cleaning Validation Program

Réf: 30715 Mardi 19 Novembre 2019 - Palo Alto US

Editorial This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory ...

Conférence & Séminaire: Management

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process ...

Réf: 30716 Mardi 19 Novembre 2019 - Palo Alto US

Editorial This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change ...

Conférence & Séminaire: Management

Validation Master Plan - The Unwritten Requirements

Réf: 30385 Mercredi 20 Novembre 2019 - Palo Alto US

Editorial This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's ...

Conférence & Séminaire: Management

Validation Master Plan - The Unwritten Requirements

Réf: 30717 Mercredi 20 Novembre 2019 - Palo Alto US

Editorial This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's ...

Conférence & Séminaire: Management

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

Réf: 30718 Mercredi 20 Novembre 2019 - Palo Alto US

Editorial Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP ...

Conférence & Séminaire: Management

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

Réf: 30756 Lundi 25 Novembre 2019 - Palo Alto US

Editorial This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental ...

Conférence & Séminaire: Management

4-Hr Virtual Training: How to Respond to an FDA Investigation

Réf: 30386 Mercredi 04 Décembre 2019 - Palo Alto US

Editorial This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by ...

Conférence & Séminaire: Management

4-Hr Virtual Training: How to Respond to an FDA Investigation

Réf: 30726 Mercredi 04 Décembre 2019 - Palo Alto US

Editorial This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by ...

Conférence & Séminaire: Management

Human Error Reduction Techniques for Floor Supervisors

Réf: 30728 Jeudi 05 Décembre 2019 - Palo Alto US

Editorial Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these ...

Conférence & Séminaire: Management

Overcoming Obstacles of The Canadian Drug Regulatory Landscape

Réf: 30729 Jeudi 05 Décembre 2019 - Palo Alto US

Editorial The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical ...

Conférence & Séminaire: Management

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Réf: 30730 Lundi 09 Décembre 2019 - Palo Alto US

Editorial This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the ...

Conférence & Séminaire: Management

FDA's Ambitious Regulation of Social Media

Réf: 30731 Mardi 10 Décembre 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 ...

Conférence & Séminaire: Management

How to Prepare for an FDA Inspection?

Réf: 30732 Mardi 10 Décembre 2019 - Palo Alto US

Editorial In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those ...

Conférence & Séminaire: Management

FDA Inspections: Understanding the Core Elements – Part I

Réf: 30733 Jeudi 12 Décembre 2019 - Palo Alto US

Editorial Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics. Objectives This course is designed to ...

Conférence & Séminaire: Management

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