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Courses

  • 1 Request Info

    GMP Environmental Monitoring for Pharmaceutical Clean Rooms

    Overview: Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs." Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.
  • 2 Request Info

    Human Error Reduction Techniques for Floor Supervisors

    Overview: Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed. 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.
  • 3 Request Info

    6-Hour Virtual Seminar on Understanding the New USP Chapter 1224 for Transfer of Analytical Methods

    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The new USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This seminar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.
  • 4 Request Info

    6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
  • 5 Request Info

    6-Hour virtual Seminar on Evolution of the Quality Management System - How to go from Surviving to Thriving

    This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers "establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured".
  • 6 Request Info

    HIPAA 2021 - Upcoming Changes

    Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump (or Biden) administration, new congressional mandates and any other applicable updates for 2021 and beyond along with changes relating to COVID19 and Information Blocking under the Cures Act (do’s and don’ts). There are an enormous amount of issues and risks for covered entities and business associates these days – we will speak to the most common violations and fines – and how to best avoid fines and headaches.
  • 7 Request Info

    OCR Compliance Plus - Step-by-Step HIPAA Risk Analysis & Risk Management

    Overview: Risk Analysis and Risk Management (RA-RM) are OCR's top enforcement priority and the basis for every HIPAA Compliance program. However, the biggest and most important nationwide HIPAA violation is failure to perform RA-RM in compliance with OCR requirements. OCR published shocking results of its Phase 2 HIPAA Compliance Audit on December 17, 2020 revealing that: 86% of covered entities and 83% of business associates failed the Risk Analysis Audit 94% of covered entities and 88% of business associates failed the Risk Management Audit
  • 8 Request Info

    Texting and E-mail with Patients: Patient Requests and Complying with HIPAA

    Overview: This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. The session will explain how to discuss communications options with individuals so that you can best meet their needs and desires, while preserving their rights under the rules. With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the regulations and meeting the e-mail and texting communication needs and desires of its providers and patients. You need the proper privacy protections for health information, and the necessary documented policies and procedures, as well as documentation of any actions taken pursuant to your policies and procedures.
  • 9 Request Info

    Medical Professional Recruitment and Retention in Difficult Areas

    Overview: Have you spent thousands of dollars on locum tenens? Do you struggle to keep clinical professionals once you get them? This is the webinar for you. Whether you find it difficult to find professionals because of the pay scale you are dealing with, the area you are in, or the preconceived notions that may be out there about your organization, this webinar will discuss some of the best practices for finding and keeping your health care providers. Why you should Attend: This webinar will provide tools and suggestions for you to help recruit and retain medical, dental, behavioral health and other types of high demand medical professionals for organizations that are in difficult to recruit areas. This includes rural areas, high crime areas and low wage areas. Areas Covered in the Session: How do we find them? Medical Dental Behavioral health
  • 10 Request Info

    6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.
  • 11 Request Info

    6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor

    Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
  • 12 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    Overview: The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
  • 13 Request Info

    Importing and Exporting Covid-19 Products

    Overview: The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these dependencies and has passed legislation to better understand and address them. An area of particular concern to Congress in the current environment is U.S. shortages of medical supplies - including personal protective equipment (PPE) and pharmaceuticals -as the United States steps up efforts to contain COVID-19 with limited domestic stockpiles and insufficient U.S. industrial capacity. PPE, antibiotics, and active pharmaceutical ingredients have led to shortages of critical medical supplies in the United States.
  • 14 Request Info

    Validation Challenges for Bioassays

    This webinar addresses the importance of method development in successfully overcoming difficult validations. Specific topics are unique challenges for cell-based methods, use of DOE to define method parameters, and creating unambiguous methods.
  • 15 Request Info

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

    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?
  • 16 Request Info

    6-Hour Virtual Seminar on Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 17 Request Info

    6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

    Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA.
  • 18 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 19 Request Info

    6-Hour Virtual Seminar on HIPAA vs. SAMHSA 42 CFR Part 2

    This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information.
  • 20 Request Info

    6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

    One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently they serve differnt purposes, support different goals, but the TD File is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TDFile. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.