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Water System Biofilm Control and Microbial Monitoring Myths

Réf: 29056 Mardi 05 Mars 2019 - En ligne

Overview   It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could ...

Formation: Pharmacie, Médecine, Bio-Technologies

Times Up! Breaking the Silence About Workplace Bullying

Réf: 29058 Jeudi 07 Mars 2019 - En ligne

Overview There are many reasons to be optimistic about our workplace. This subject is not one of them and we need to address it straight on. Since October 2017, we have just seen the tip of the proverbial iceberg with the #MeToo and #TimesUp movements. Those hashtags have been joined by a third ...

Formation: Médecine, Bio-Technologies, Santé Publique, Pharmacie

The FDA Inspection: Preparation, Management, and Follow - up

Réf: 28693 Vendredi 08 Mars 2019 - En ligne

Overview: This webinar is designed to teach participants how to utilized MBSR techniques as a means to reduce stress and burnout, promote positive workplace functioning, and improve job satisfaction and productivity.    Why should you Attend: The FDA inspection is the most nerve-...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

Implementing a Robust Data Integrity Program- 2019

Réf: 28694 Lundi 11 Mars 2019 - En ligne

Overview: Attendees will be presented with an overview of the audit trails within an application and the content of each one, Also Attendees will be presented with a list of records to identify if they are GMP records.   Why should you Attend: The regulatory concern has been ...

Formation: Pharmacie, Médecine, Bio-Technologies, Toxicologie, Santé Publique

Implementation and Management of GMP Data Integrity

Réf: 29059 Lundi 11 Mars 2019 - En ligne

Overview Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

OneNote 2016 - Bringing Order to your Digital Chaos

Réf: 28695 Mardi 12 Mars 2019 - En ligne

Overview: Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.   Why should you Attend: Learn how OneNote can make you more productive while helping you to manage your meetings, your projects and your ...

Formation: Médecine, Bio-Technologies, Toxicologie, Santé Publique

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

Réf: 28696 Mardi 12 Mars 2019 - En ligne

Overview: In this webinar you will Learn how to navigate through FDA requirements, Ways to manage your presence in social media, How to identify an off-label problem and corrective action.   Why should you Attend: Limitations on commercial free speech Avenues of off-label ...

Formation: Médecine, Bio-Technologies, Toxicologie, Santé Publique

Virtual Seminar on FDA's Scrutiny of Social Media Promotion

Réf: 29060 Mardi 12 Mars 2019 - En ligne

Overview FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under ...

Formation: Médecine, Bio-Technologies, Santé Publique, Toxicologie

What is Human Factors and why is it Important?

Réf: 29061 Mercredi 13 Mars 2019 - En ligne

Overview This webinar is tailored to provide an overview of human factors and the benefits of applying human factors within the design process and ongoing system operations. Human Factors can be classified into three areas: Ergonomics Human Performance Organizational ...

Formation: Médecine, Bio-Technologies, Toxicologie, Santé Publique, Pharmacie

FDA's Quality Metrics - Latest Advances

Réf: 29062 Jeudi 14 Mars 2019 - En ligne

Overview This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement

Réf: 28698 Vendredi 15 Mars 2019 - En ligne

Overview: This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.   Why should you Attend: This guidance was first issued in 1983, and the main points of ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

Theory and Practice of Near-Infrared Spectroscopy

Réf: 28699 Vendredi 15 Mars 2019 - En ligne

Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts.   Why should you Attend: These can be hand-held, lab-based, or installed in process lines This ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management, Santé Publique

Onboarding: From Entry-Level to Senior Executive

Réf: 29063 Vendredi 15 Mars 2019 - En ligne

Overview Imagine yourself walking into the office on the first day of your very first real full-time job. You are terrified. There is so much you need to learn and you are hoping you won't make some huge embarrassing mistakes. Imagine yourself walking into the office on the first day of your ...

Formation: Médecine, Bio-Technologies, Toxicologie, Santé Publique

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 ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

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 ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

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 ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

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 ...

Formation: Pharmacie, Médecine, Bio-Technologies

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 ...

Formation: Médecine, Bio-Technologies, Toxicologie, Santé Publique

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 ...

Formation: Médecine, Bio-Technologies, Santé Publique, Pharmacie

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 ...

Formation: Médecine, Bio-Technologies, Santé Publique, Pharmacie

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 ...

Formation: Médecine, Bio-Technologies, Informatique, Santé Publique, Pharmacie

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 ...

Formation: Médecine, Bio-Technologies, Informatique, Santé Publique

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 ...

Formation: Médecine, Bio-Technologies, Informatique, Santé Publique

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 ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique, Informatique

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 ...

Formation: Médecine, Bio-Technologies, Santé Publique, Pharmacie

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