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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

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

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

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

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

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

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

Creating a Drama Free Workplace

Ref: 29057 Wednesday March 06th, 2019 - Online

Overview   Workplace drama sucks the productivity out of a team or organization. It also creates an inhospitable environment where healthy people don't want to work so they leave. Good, productive people leave the organization. In fact, the best people, the highest performers, the self-...

Education: Medicine, Pharmacy, Toxicology, Public Health

Turn a Culture of Quality Into a Competitive Advantage

Ref: 29042 Tuesday April 23rd, 2019 - Online

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 ...

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

Controlled Document System for a Life Sciences Manufacturing Plant

Ref: 29041 Thursday April 18th, 2019 - Online

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 ...

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

How to Implement MDSAP-Requirements into your ISO 13485

Ref: 29040 Monday April 15th, 2019 - Online

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 ...

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

Data Integrity: Compliance with 21 CFR Part 11

Ref: 29039 Thursday April 11th, 2019 - Online

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 ...

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

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Ref: 29038 Wednesday April 10th, 2019 - Online

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 ...

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

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

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

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

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

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

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

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

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

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

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

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

What is Human Factors and why is it Important?

Ref: 28697 Wednesday March 13th, 2019 - Online

Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals.   Why should you Attend: Understand the definition and scope of human ...

Education: Medicine, Pharmacy, Public Health

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