• TRAINING AND COACHING

    Our current and potential clients who are looking to grow or improve their regulatory compliance commitments, are often in need of learning and understanding about the numerous areas addressed by the RCM core capabilities. Although some information can be found on the Internet or through pre-recorded training sessions, the clients are often left underwhelmed by these generalized options, with their particular questions still unanswered and their funds expended to gain a questionable value.

    Understanding this need, RCM Training and Coaching services’ delivery provides, but by no means is limited to, these specific values:

    1. A free consultation with an RCM Trainer/Coach to understand the unique organizational training needs and the value the training will provide, as well as discuss any other relevant topics before any commitment
    2. Training that is based both on the theoretical dogmas and the real-life scenarios encountered in RCM’s many years of experience, including examples from case studies of our previous successful projects
    3. Training that is customized to the expected audience, from the “as needed” level of detail to the delivery methods
    4. An option to customize the training to meet the individual organizational needs, with the ultimate goal of delivering the most value and effect
    5. Engaging a true Subject Matter Expert not only to deliver the training, but also to answer any questions and participate in a real-time discussion on the relevant topic
    6. Scheduling flexibility that allows an RCM Trainer/Coach to be present at a client’s site for personal and effective training
    7. Etc.


    RCM offers Training and Coaching in the below areas of competency, from high level introduction to in-depth technical coverage).

    Please contact us for the training needs relevant to any topics that may not be listed.


    IT Compliance

    • 21 CFR Part 11 – History, Introduction, in-depth view of the requirements
    • Meeting Part 11 requirements for regulated organizations
    • Meeting Part 11 expectations for industry vendors
    • EU Annex 11
    • Project and Operational Compliance expectations


    Quality Management Systems and Methodology

    • IT-centric Quality Management Systems for regulated organizations
    • IT-centric Quality Management Systems for industry vendors
    • Vendor audits for regulated organizations
    • Vendor audits for industry vendors


    Computerized Systems Validation (CSV) and Infrastructure Qualification

    • CSV Lifecycle, documentation and activities
    • Real-life strategies for successful and effective CSV execution
    • Risk-Based Approach to Validation (based on GAMP5 doctrines)
    • CSV requirements for systems initial deployment
    • CSV requirements for systems operations and changes
    • Meeting Infrastructure Qualification requirements at IT organizations


    Start With a Phone Call

    Speak with one of our SME's. The result may be:

    • Advice
    • Free Consultation
    • Gaining a trusted advisor and networking partner

    Our offerings are as flexible as our clients’ needs and range from staff augmentation to
    scalable turn-key solutions and we look forward to hearing from you.