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Courses

  • 1 Request Info

    Strategies To Prevent Manufacture And Distribution Of Substandard Medications

    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 according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. Examples of potential dangers that can occur include temperature excursions, inappropriate use, and unsafe ingredients inadvertently added to the product.
  • 2 Request Info

    Test Method Validation to Verify the Performance of a Medical Device

    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 error from the test method itself. Why should you Attend: This webinar will help you better understand Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.
  • 3 Request Info

    Audit Trail Generation and Review 2019

    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 how to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.
  • 4 Request Info

    Webinar on The Problem of Bacterial Spores and Sporicidal Disinfection

    Learn the origins and risks of spores, strategies to reduce incidents and incorporation of sporicidal agents into the contamination control program. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/The-Problem-of-Bacterial-Spores-and-Sporicidal-Disinfection-505059/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 5 Request Info

    Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations More: https://www.globalcompliancepanel.com/seminar/applied-statistics-with-emphasis-verification-901933SEMINAR/?SEO
  • 6 Request Info

    Patient Communications, E-mail, and Texting - How to Meet Patient Requests for Information and Stay Within the HIPAA Rules

    This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate e-mail and texting into your organization in a compliant way, learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires.
  • 7 Request Info

    Practical strategies for Meeting the Needs of Teens and Adolescents with ASD

    Overview: When working or living with an adolescent with an Autism Spectrum Disorder, meltdowns may occur that may be a result of sensory overload, cognitive overload or due to inability to self-regulate emotions. Communication skills impact social skills which then lead to behavior problems. Recognizing those signs which are the rumbling stages of an eruption may be the key to preventing more serious behaviors.
  • 8 Request Info

    Performing a Risk Assessment - Methodology and Steps for Success

    Overview: The Risk Assessment which is required by the HIPAA Security Rule is often overlooked, misunderstood, or it seems to be too complex to even find a starting point. What some organizations find out is that while they brought in a third party auditor to do a "IT network assessment' that they actually did not end up performing a full blow risk assessment.
  • 9 Request Info

    Treatment Planning for Mental Health Providers

    Overview: Clinical treatment planning in any mental health setting is often thought of as a necessary routine that must be completed in order to provide a guide for patient course. Practitioners may treat the planning process with a cavalier approach, particularly after having completed many plans within their clinical setting.This training is designed to assist both newly minted mental health practitioners as well as seasoned professionals. While the program is filled with practical steps, tools and advice, it also allows for creativity and independent critical thinking skills to be applied to the process. First, participants will learn the importance of investing in the treatment planning process in a manner that provides immediate continuity and connection with the patient and their presenting symptoms.This initial part of the training explains the FUN in treatment planning.
  • 10 Request Info

    Why Medication is Usually Contraindicated in the Treatment of Panic: What is 90% Effective

    Overview: Panic attacks are amongst the most dreaded of mental health problem. The most effective strategy for relieving panic attacks is interoceptive exposure (IE) which involves systematically bringing on the symptoms such that the person habituates and desensitizes to them.
  • 11 Request Info

    Ethical Challenges in a Digital World and Ethical Decision-making Strategies

    Overview: Today's behavioral health practitioners face a wide range of unprecedented ethical challenges related to their use of digital and other technology. Is it ethical for practitioners (mental health counselors,social workers, psychologists, psychiatrists, marriage and family therapists, and substance use counselors) to use technology to provide services remotely to clients they never meet in person?
  • 12 Request Info

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

    Overview This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections.
  • 13 Request Info

    Implementation and Management of GMP Data Integrity

    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 the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.
  • 14 Request Info

    Theory and Practice of Near-Infrared Spectroscopy

    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. The logic of how various types of NIR equipment is designed and operated, how it obtains and generates spectra, how the software generates results and can control processes. This webinar will instruct the participants how to: Evaluate whether or not NIR is the best technology for an application What type of instrument would work best (level of sensitivity needed) How to write SOPs for operation, calibration, validation, and maintenance of NIR instruments
  • 15 Request Info

    Webinar on Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

    Understand how to have a structured approach to minor component identification and quantitation of low-level compounds for impurity and degradation. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Identification-and-Quantitation-of-Low-Level-Compounds-for-Impurity-and-Degradation-Analyses-502236/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 16 Request Info

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

    Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
  • 17 Request Info

    2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size. The statistical methods discussed during the webinar include the following: Confidence intervals Process Control Charts Process Capability Indices Confidence / Reliability Calculations MTBF Studies ("Mean Time Between Failures" of electronic equipment) QC Sampling Plans
  • 18 Request Info

    Tricks To Get The [Most Out] Of Your Device Master Records

    Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
  • 19 Request Info

    Medical Devices - ISO 13485

    Overview: A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
  • 20 Request Info

    Handling Situations Where Regulation (E and ACH) Don't Align

    Overview: This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and loss.