• John Robinson

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  • 6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

    6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

    Medical Sciences Fremont (California) May 21, 2021 Check with publisher

    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 c...

  • 6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

    6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

    Medical Sciences Fremont (California) May 21, 2021 Check with publisher

    This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulator...

  • EU Regulatory Affairs Strategy During Development of Medicinal Products

    EU Regulatory Affairs Strategy During Development of Medicinal Products

    Medical Sciences Fremont (California) May 21, 2021 Check with publisher

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regul...

  • 6-Hour Virtual Seminar on Data Integrity

    6-Hour Virtual Seminar on Data Integrity

    Medical Sciences Fremont (California) May 21, 2021 Check with publisher

    The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant f...

  • 6-Hour Virtual Seminar - Batch Record Review and Product Release

    6-Hour Virtual Seminar - Batch Record Review and Product Release

    Medical Sciences Fremont (California) May 21, 2021 Check with publisher

    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 c...

  • 6-Hour Virtual Seminar on Master Class for the HIPAA Officer

    6-Hour Virtual Seminar on Master Class for the HIPAA Officer

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, such as Individual Rights and Uses & Disclosures, and recent and expected changes to HIPAA and other rules such a...

  • 6-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

    6-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices. Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for...

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

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

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    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...

  • 6-Hour Virtual Seminar on HIPAA Bootcamp for the Security Officer

    6-Hour Virtual Seminar on HIPAA Bootcamp for the Security Officer

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    This 6-hour seminar 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 u...

  • 6-Hour Virtual Seminar on Microsoft Outlook on Steroids

    6-Hour Virtual Seminar on Microsoft Outlook on Steroids

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.If you are using Outlook mainly to send and receive email and to record appointments and meetings, about 85% of the power of Microsoft Outlook is be...