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Courses

  • 41 Request Info

    US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

    This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. The seminar will discuss in detail the: Types of inspections done by US FDA, EMA and PMDA Typical Audit Agenda that can be expected by each Authority Scope of Audits.........how many auditors, how many days When audits will likely occur The expectation differences between inspections of API and Finished Product facilities What areas of GMP become a focus by region
  • 42 Request Info

    Validation and 21 CFR Part 11 Compliance of Computer Systems

    We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: 21 CFR Part 11 and Computer Validation: Why so many citations? Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11 Data Integrity vs Computer Systems Validation Overview and Key Requirements of Part 11 & CSV How to use a Risk Based Assessment to reduce work while still achieving Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
  • 43 Request Info

    FDA Scrutiny of Promotion and Advertising Practices

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
  • 44 Request Info

    Strategies for Improving Effectiveness and Efficiency of your Quality Management System

    This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality and compliance as well as optimizing the cost of quality. This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.
  • 45 Request Info

    2-day In-person Seminar 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
  • 46 Request Info

    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
  • 47 Request Info

    Complaint and Recall Management: A Compliant, Lean Program

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback.
  • 48 Request Info

    Learning Management Systems (LMS)

    This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula. A Pharma curriculum is the sum total of all the courses that an employee in a specific position requires, and is composed of smaller groups of courses called modules. A curriculum typically will include a "core curriculum" (usually several modules) with all the required courses for all employees involved in GMP functions, a "job-specific" group of courses for the position, modules reflecting further subdivision of responsibilities within individual positions, roles in validated computer systems such as investigations, and roles in applicable hard-copy review processes.
  • 49 Request Info

    SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies. To achieve the goal of an SOP that has adequate but not excessive detail, the course will define the parameters of an effective SOP and provide a solid foundation that will have a positive impact on training and job performance. Conversely, the negative impact of poorly written procedures on production and compliance will also be explored.
  • 50 Request Info

    Japan Regulatory Compliance Requirements for Life Science Products

    This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
  • 51 Request Info

    The Next Level of Private Practice - Risk, Referrals, Retention & Resilience

    The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice owner; meaning that is both general as well as highly specialized and unique to each healthcare practice. As this 2-day training commences, the four R's are introduced and explained in general terms, along with a discussion of how this highly successful business development process came into existence.
  • 52 Request Info

    Uncovering and Managing Successful Post Market Compliance for Medical Devices

    Customer satisfaction plays a significant role in measuring a product's postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).
  • 53 Request Info

    HIPAA 2018 - Staying Competitive and Complying with HIPAA

    In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive. Also, managing risks is critical to reducing exposure from breaches or cybercrime.
  • 54 Request Info

    Tissues and Cellular and Tissue-Based Products (HCT-Ps)

    Overview: This course offers extensive examination of the FDA's regulations of biological products such as HCT/Ps from pre-clinical testing to post-marketing regulatory requirements. Specific ethical and regulatory considerations will be discussed for various HCT/Ps. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products.
  • 55 Request Info

    Understanding the HIPAA/HITECH Requirements

    This one-day seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA. I want to add clarity for compliance officers. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.
  • 56 Request Info

    Living with Depression - Unveiled 2018

    Major depression is a huge challenge in today's society with approximately more than one in 15 people having suffered from a major depressive episode in the last year. Depression is seen in both sexes and in all ages, including children, although it's more common among females and those age 40-59. But many people suffer with depression needlessly because they don't know what depression really is and don't get appropriate treatment. While anyone can write a list of clinical symptoms, it's how depression manifests in real people that really makes a mark.
  • 57 Request Info

    Hosting FDA Regulatory Inspections 2018

    The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.
  • 58 Request Info

    Compliance for Computer Systems Regulated by FDA

    The seminar 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.
  • 59 Request Info

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Overview: Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations. By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement.
  • 60 Request Info

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.