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Courses

  • 1 Request Info

    Guidance for Lubricants in Food Applications

    Overview: Over application or incorrect usage of lubricants can lead to insanitary conditions or contamination. Often condensate plays a big part in refrigerated foods and mixed with improper use of lubricants can spell potential problems in the environment. Why should you Attend: FDA at one time approved and updated a lubricant listing for the food industry. This is now the responsibility of manufactures to manage.
  • 2 Request Info

    FDA's New Enforcement of 21 CFR Part 11

    Overview: The webinar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
  • 3 Request Info

    Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

    Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.
  • 4 Request Info

    Statistical Process and Quality Control : 2-Day In-Person Seminar

    The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.
  • 5 Request Info

    3-Hour Virtual Seminar on Patient Communications, E-mail, and Texting

    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.
  • 6 Request Info

    HIPAA and the IT Manager

    Overview: This lesson will be going into great detail regarding the practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 7 Request Info

    Developing HIPAA Policies and Procedures

    Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. A HIPAA Risk Management plan is your overall policies and procedures manual. If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards.
  • 8 Request Info

    HIPAA Compliance for Attorneys and Law Firms

    Overview: This lesson will be addressing how law firms who work with protected health information need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days as it relates to patients' ability to sue and the Federal governments audit process. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit risks to your firm by simply taking proactive steps and utilizing best practices.
  • 9 Request Info

    2-Hour Virtual Seminar on Physician Employment Agreements, Contractor Agreements & Legally Compliant Compensation Models

    This webinar discusses the selection and employment contracting process that follows the identification of a suitable opportunity, You should attend this webinar to gain an understanding of what should and what should not be in a physician employment agreement, However, the agreement serves to protect against future disputes.
  • 10 Request Info

    HIPAA and Human Resources

    Overview: This lesson will be addressing what human resources managers need to know regarding health records of their employees. We will go through "do's and don'ts"and cover many frequently asked questions I have received through my 17-year career in HIPAA compliance. Human resources managers need to get their HIPAA house in order as this law is now fully enforced across the board and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019 and beyond.
  • 11 Request Info

    Explores New SAMHSA Confidentiality Law for Substance Use Disorder Records(42 CFR Part 2)

    This webinar will guide healthcare professionals, health IT vendors, and insurance companies to maintain information security and patient confidentiality
  • 12 Request Info

    Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

    Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive. Though some excursions are real and a sign of system control problems, most are probably self-inflicted, being caused by poorly designated "trigger values", poorly designed use points, or poorly executed sampling or testing. This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary.
  • 13 Request Info

    Preparing for OSHA Voluntary Protection Program (VPP)

    Overview: The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization. This training program will guide attendees with best practices in implementing the OSHA VPP program. There are five cornerstones or elements for VPP: Management commitment; Employee involvement; Workplace Analysis; Hazard Prevention and Control; and Training. Define the key elements and sub elements of the OSHA VPP program Learn how to get a baseline of the safety culture within your facility
  • 14 Request Info

    Medical Device Software Validation Meeting FDA Regulations

    Overview: This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.
  • 15 Request Info

    Responsibilities of the Carrier Under the Final FDA FSMA Rules

    Overview: This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws. Session 1, "Responsibilities of the Carrier Under the Final Rules" covers the Final Rules on the Sanitary Transportation of Human and Animal Foods (now law) as published by the Food and Drug Administration under the Food Safety Modernization Act (FSMA). This session covers the final rules. All carrier transportation operations personnel are required to take this and the subsequent two training sessions.
  • 16 Request Info

    Tools for Human Error Reduction

    Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally 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.
  • 17 Request Info

    21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures

    Overview: 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.
  • 18 Request Info

    Statistical Justification for Sample Size and the Use of Only 3 Lots

    Why should you Attend: Almost all manufacturing and development companies perform at least some process validation studies, but it is difficult to decide how many Lots to include in the study and how large the Sample per Lot should be. This webinar provides a "statistical" justification and method for determining Sample Sizes, and a statistical justification for using only 3 Lots (which is the typical number, especially in industries regulated by the FDA).
  • 19 Request Info

    FDA Inspections: From SOP to 483 in (2019)

    Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? Why should you Attend: This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
  • 20 Request Info

    Investigation and Root Cause Analysis to Meet FDA Expectations

    Overview: This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes. Why should you Attend: We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.