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Courses

  • 1 Request Info

    Avoiding Critical R&D Formulation/Drug Delivery Errors

    We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies— technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved.
  • 2 Request Info

    How to Deal With the Disruptive Practitioner

    Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner’s privileges and medical staff membership. You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior. We will discuss the elements of an effective policy and the actions that should be taken to develop progressive discipline and/or sanctions that should be taken before taking action under the corrective action procedures.
  • 3 Request Info

    Effective Batch Record Review

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 4 Request Info

    2017 HIPAA Changes

    This lesson will be addressing how practice/business managers (or compliance offers) 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, Trump administration, and any other applicable updates for 2017 and beyond.
  • 5 Request Info

    Countdown to MACRA: It's Time for Physicians to Pick Their Pace for 2017

    On October 14th CMS published the final rule that outlines its implementation of MACRA value-based payment reform starting in 2017. The new framework is called the Quality Payment Program. Going forward, clinicians and health care leaders need to be developing strategies so they can position their organizations for financial success under the new Quality Payment Program. Beginning in 2017, CMS will start rewarding clinicians for their delivery of high-quality patient care through one of two pathways: (1) payment of incentives for participation in Advanced Alternative Payment Models (Advanced APMs); or (2) application of a positive or negative adjustment pursuant to the clinician's performance under the new Merit-based Incentive Payment System (MIPS).
  • 6 Request Info

    Pharma Analytics – I Have All These Data, Now What Do I Do?

    We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability the opportunity to use data to develop and improve processes becomes even greater. Particular attention is paid to the pedigree of the data: the process that generated the data, the measurement process and the data collection process including the sampling schemes used. Also essential to success is the use of subject matter knowledge to frame the problem and assess and interpret the results of the analysis.
  • 7 Request Info

    Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

    Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
  • 8 Request Info

    Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

    The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. The program was launched in November 2001, with seven large U.S. companies as the initial participants. By the end of 2014, more than 10,000 members joined the effort. More than 4300 importers in the program account for more than half of the value of all merchandise imported into the U.S. C-TPAT certification can be attained by companies who seek to be considered low risk, enabling their cargo to be processed in an expedited manner with fewer Customs examinations. The certification involves a documented process for determining and mitigating risk throughout a company’s international supply chain. The program is voluntary, but affords those participating in it a huge advantage in terms of international trade.
  • 9 Request Info

    Best Validation Practices for Laboratory Computer Systems Regulated by FDA

    Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators. For more detail please click on this below link: http://bit.ly/2r9k1XA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515
  • 10 Request Info

    How to properly investigate OOS/OOT Results

    Overview The speaker will provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations. This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed. For more detail please click on this below link: http://bit.ly/2ru2Sae Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 11 Request Info

    HIPAA Audits – an Insider’s Perspective

    Overview I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I’ve been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This HIPAA training will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. For more detail please click on this below link: http://bit.ly/2tkL7wD Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 12 Request Info

    Controlling human error in the manufacturing floor

    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. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. For more detail please click on this below link: http://bit.ly/2v1A8Zz Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 13 Request Info

    Managing Your FDA Inspection: Before, During and After: 2-Day In-Person Seminar by Ex-FDA Official

    FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. Who will Benefit: When you interact with the FDA, you need to look at yourself through FDA’s eyes. You can understand the purpose of an inspection, what the investigator will do and what it means for you. Once you learn how to read the signals you are better equipped to mitigate regulatory damage and, best of all, take the drama and mystique out of an inspection. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 14 Request Info

    Data Integrity: FDA/EMA Requirements and Implementation : 2-Day In-Person Seminar by Ex-FDA Director

    The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).
  • 15 Request Info

    Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error in the manufacturing floor and GMP environment

    Dr. Ginette Collazo — a 20-year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more — will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics.
  • 16 Request Info

    Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

    Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.
  • 17 Request Info

    Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR : 2-Day In-Person Seminar

    This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
  • 18 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.
  • 19 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.
  • 20 Request Info

    Aseptic Processing Overview and Validation :2-Day In-Person Seminar

    This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.