Congrès médecine - Formation médecine

Device Changes, FDA Changes, and the 510(k)-2019

Réf: 28700 Mercredi 20 Mars 2019 - En ligne

Overview: Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?   Areas Covered in the Session: Is the process "risk based"? K-97-1 and the FDA's "Decision ...

Dealing with OCD in the Office

Réf: 29064 Mercredi 20 Mars 2019 - En ligne

Overview A person at work re-reading a report over and over and over takes time and may never be completed because it cannot be done perfectly. A person late for work too many times because of fear that they did not lock the door and need to check may be fired. When cleanliness at home takes ...

FDA Inspections - Do's and Don'ts 2019

Réf: 28701 Vendredi 22 Mars 2019 - En ligne

Overview: In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.   Why should you Attend: This session will discuss how to prepare for the ...

Secrets to Writing Effective SOPs for Medical Device QMS

Réf: 29065 Lundi 25 Mars 2019 - En ligne

Overview Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is ...

Compliance with the New ICH GCP Revision 2 Addendum

Réf: 29031 Lundi 01 Avril 2019 - En ligne

Overview: This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.   Why should you Attend: With the new ICH GCP E6 Revision 2 Addendum now finalised ...

Understanding and Implementing a Technology Transfer Process

Réf: 29032 Lundi 01 Avril 2019 - En ligne

Overview: Identify elements of the business process framework for managing    technology transfers. Explain benefits of technology transfer.    Determine elements of a successful technology transfer.   Why should you Attend: This presentation will ...

Audit Trail Generation and Review 2019

Réf: 29033 Mercredi 03 Avril 2019 - En ligne

Overview: These electronic records must be maintained according to regulatory    requirements contained within FDA's 21 CFR Part 11 for US    jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.   Why should you Attend: Attendees will learn ...

Supply Chain Traceability is Going Digital [What You Can Do to Prepare]

Réf: 29034 Mercredi 03 Avril 2019 - En ligne

Overview: Recall requires traceability data that tells what food is in the stream,    where it is located and recall systems must be able to provide such    information in real time. Reducing recall time means reducing    illness, the loss of life and ...

Test Method Validation to Verify the Performance of a Medical Device

Réf: 29035 Jeudi 04 Avril 2019 - En ligne

Overview: Those who work with process optimization and validation focus on    optimizing a process and reducing variability. Those working on Test    Method Validation, on the other hand, focus on discerning between    process variation and measurement ...

Best Mastering Excel Formulas and Functions 2019

Réf: 29036 Lundi 08 Avril 2019 - En ligne

Overview: Functions are built-in formulas that have been programmed to    perform a specific calculation. They range from the simple such as    SUM and AVERAGE (used to calculate the total and average of    numbers in a range of cells) to the powerful ...

FDA's New Import Program for 2019

Réf: 29037 Mardi 09 Avril 2019 - En ligne

Overview: In this interactive session author will discuss about the FDA's    required information for the PREDICT software screening prior to    entry and Custom's Harmonized Tariff Schedule (HTS).   Why should you Attend: The new import entry filing ...

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Réf: 29038 Mercredi 10 Avril 2019 - En ligne

Overview: In this webinar we will provide you with best practices that have    been proven effective, and equip you with the means to advocate for    these ideas within your organization.   Why should you Attend: If a legitimate product is not manufactured ...

Data Integrity: Compliance with 21 CFR Part 11

Réf: 29039 Jeudi 11 Avril 2019 - En ligne

Overview: This webinar describes exactly what is required for compliance with    Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud    hosted applications.   Areas Covered in the Session: What 21 CFR Part 11 means today Purpose of Part ...

How to Implement MDSAP-Requirements into your ISO 13485

Réf: 29040 Lundi 15 Avril 2019 - En ligne

Overview: How a smart implementation of these requirements in the quality    management system is possible and finally how the audit for five    countries (Australia, Brazil, Canada, Japan, US) is working.   Why should you Attend: Your implementation time ...

Controlled Document System for a Life Sciences Manufacturing Plant

Réf: 29041 Jeudi 18 Avril 2019 - En ligne

Overview: Life science manufacturing plants have the additional responsibility    to ensure that each and every step of the manufacturing process is    controlled by work instructions, SOPs, set-up instructions, equipment    maintenance, and support ...

Turn a Culture of Quality Into a Competitive Advantage

Réf: 29042 Mardi 23 Avril 2019 - En ligne

Overview: A culture of quality is a powerful tool for creating an effective and    efficient Quality Management System. A culture of quality is not    accidental but can be purposefully nurtured and developed.   Why should you Attend: Every organization ...

Quality Risk Management Overview 2019

Réf: 29275 Jeudi 02 Mai 2019 - En ligne

Overview: Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.   Why should you Attend: It can ...

Quality Control for Microbiological Media and Reagents

Réf: 29276 Vendredi 03 Mai 2019 - En ligne

Overview: This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests.   Why should you Attend: In microbiology laboratories, there are a wide array and ...

Statistical Hypothesis Tests: Concepts and Applications

Réf: 29277 Mardi 07 Mai 2019 - En ligne

Overview: This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes.   Why should you Attend: This webinar will lay the ...

Architect and Implement Solution 2019

Réf: 29279 Mardi 07 Mai 2019 - En ligne

Overview: We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization.   Why should you Attend: The FFIEC is a wonderful guideline that banks are supposed to follow, but the interpretation of the guideline ...

How to Create a Medical Software Development File - ISO 62304

Réf: 29280 Lundi 13 Mai 2019 - En ligne

Overview: You will learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.   Why should you Attend: You should attend this webinar to understand, what is the ISO 62304 for medical software and how is the ISO ...

FDA's Quality Metrics - Latest Advances

Réf: 29281 Vendredi 24 Mai 2019 - En ligne

Overview: This is a very important webinar for the FDA who is planning to use the quality metrics as part of their risk based inspection process.   Why should you Attend: This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk ...

How to conduct a Compliance Gap Analysis for ERM

Réf: 29282 Vendredi 24 Mai 2019 - En ligne

Overview: This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.   Why should you Attend: Many companies today are "short staffed" and may skip vital steps that are ...

Overcoming Obstacles of the Canadian Drug Regulatory Landscape

Réf: 29283 Mardi 28 Mai 2019 - En ligne

Overview: Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions and misunderstandings.   Why should you Attend: We will share insights and practical examples that facilitate a positive, ...

Logiciel médical est pour contrôler les paramètres biologiques et l'analyse graphique chez les patients

Réf: 27055 Mercredi 01 Juillet 2020 - Par correspondance

Logiciel médical est pour contrôler les parameters biologiques, l'analyse graphique et décision thérapeutique
https://sites.google.com/site/acupuncturaclasica/logiciel-medical