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Courses

  • 501 Request Info

    What you need to know to Meet FDA and International Quality Standards

    Overview: This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why should you Attend: Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.
  • 502 Request Info

    What's Changing for Life Science Product License Holders (BREXIT)

    Overview: The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward. The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.
  • 503 Request Info

    When Conducting cGMP Regulatory Inspections 2019

    Overview: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.
  • 504 Request Info

    When to Submit a 510(k) for a Change to an Existing Device

    Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
  • 505 Request Info

    Why is FDA at my facility, and what do I do during an inspection 2017

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 506 Request Info

    Why Measure Drug Plasma Levels | Drug Dissolution Testing 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901498SEMINAR?trainingregistry-February-2018-SEO
  • 507 Request Info

    Why you Should be Worried about HIPAA 2017

    This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901046SEMINAR?trainingregistry-September-2017-SEO
  • 508 Request Info

    Why you Should be Worried about HIPAA 2017

    This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901048SEMINAR?trainingregistry-December-2017-SEO
  • 509 Request Info

    Working With Challenging Parents: Strategies and Techniques

    This OnDemand Webinar will provide strategies and tools not just to cope with parents but also to be more effective in making a difference.
  • 510 Request Info

    Writing and implementing effective SOP's 2017

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900912SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 511 Request Info

    Writing and implementing effective SOP's 2017- Before 30 April 50% Discount for its All Seminars

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900914SEMINAR?trainingregistry_SEO
  • 512 Request Info

    You can do a Lot More than you Think

    This course offers 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 issues, Also we will discuss why supervision is so important in reducing and preventing human error, And also you will learn how to measure human error rates at your department and keep track of metrics.
  • 513 Request Info

    Your Most Burning Questions About Fishbone Diagramming 2019

    Overview: Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling Critical Path Analysis Value Stream Mapping Failure Mode Effects Analysis