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HIPAA 2019 - Staying Competitive and Complying with HIPAA

Ref: 28788 Wednesday February 20th, 2019 - Online

Paul Hales will capture your attention with visual presentations and
interactive learning exercises that take mystery and fear out of HIPAA Compliance.

Education: Pharmacy, Medicine, Bio-Technologies, Public Health, Toxicology

Water System Biofilm Control and Microbial Monitoring Myths

Ref: 29056 Tuesday March 05th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies

Times Up! Breaking the Silence About Workplace Bullying

Ref: 29058 Thursday March 07th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

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

Ref: 28693 Friday March 08th, 2019 - Online

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-...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Implementing a Robust Data Integrity Program- 2019

Ref: 28694 Monday March 11th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Toxicology, Public Health

Implementation and Management of GMP Data Integrity

Ref: 29059 Monday March 11th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

OneNote 2016 - Bringing Order to your Digital Chaos

Ref: 28695 Tuesday March 12th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

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

Ref: 28696 Tuesday March 12th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

Virtual Seminar on FDA's Scrutiny of Social Media Promotion

Ref: 29060 Tuesday March 12th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Public Health, Toxicology

What is Human Factors and why is it Important?

Ref: 29061 Wednesday March 13th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health, Pharmacy

FDA's Quality Metrics - Latest Advances

Ref: 29062 Thursday March 14th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

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

Ref: 28698 Friday March 15th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Theory and Practice of Near-Infrared Spectroscopy

Ref: 28699 Friday March 15th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Management, Public Health

Onboarding: From Entry-Level to Senior Executive

Ref: 29063 Friday March 15th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

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

Ref: 28700 Wednesday March 20th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Dealing with OCD in the Office

Ref: 29064 Wednesday March 20th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

FDA Inspections - Do's and Don'ts 2019

Ref: 28701 Friday March 22nd, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Secrets to Writing Effective SOPs for Medical Device QMS

Ref: 29065 Monday March 25th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies

Compliance with the New ICH GCP Revision 2 Addendum

Ref: 29031 Monday April 01st, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

Understanding and Implementing a Technology Transfer Process

Ref: 29032 Monday April 01st, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

Audit Trail Generation and Review 2019

Ref: 29033 Wednesday April 03rd, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

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

Ref: 29034 Wednesday April 03rd, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Computer science, Public Health, Pharmacy

Test Method Validation to Verify the Performance of a Medical Device

Ref: 29035 Thursday April 04th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Computer science, Public Health

Best Mastering Excel Formulas and Functions 2019

Ref: 29036 Monday April 08th, 2019 - Online

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 ...

Education: Medicine, Bio-Technologies, Computer science, Public Health

FDA's New Import Program for 2019

Ref: 29037 Tuesday April 09th, 2019 - Online

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 ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health, Computer science

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