Compliance Training Webinars for Regulated Industries

This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.

This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold.

This webinar will provide you tools and processes to verify a candidate’s qualifications in experience, education, character and work ethics. It will cover legal guidelines in doing reference and background checks.

This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted.

This 4-hr training will address both the legal and psychological issues that often arise while dealing with Psychiatric Disabilities at Work. You will learn to deal with sensitive and challenging scenarios and directly address mental health problems with managers and employees.

This training will show how the CobIT and ITIL Frameworks can be aligned to enable process maturity analysis, adherence with compliance mandates and process improvement initiatives.

This Listeria Prevention training will cover HAACP requisites as well as GMP and Sanitation programs to address areas of possible listeria contamination and methods to eradicate them.

This 90-minute Internal Audit webinar will cover the three foundational elements that support an effective Internal Audit program - establishing Internal Audit Program objectives, developing audit plans, and writing effective non-compliances.

This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada. It is designed to help the audience with their global compliance and regulatory intelligence, which is necessary to streamline the regulatory process in an organization to achieve sustainability and to remain sustainable and competitive in global markets. This seminar is a “How To Guide” intended to streamline the decision-making process in a systematic manner.

This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors.

This 3-hr virtual seminar on HIPAA Security Rule Compliance and Risk Analysis will present an organized and simple approach to perform an effective Information Security Risk Analysis and reduce your organization’s exposure to breaches and penalties. Examples of real situations will be presented and new procedures to reduce risks will be discussed.

This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document.

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.

This 3-hr virtual seminar on OSHA Subpart Z (or IH) Regulations will discuss many of the individual standards as well as the general model and approach and “template” that OSHA takes with these IH regulations.

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

This 3-hr virtual seminar on the New Changes to the HIPAA Regulations will discuss the details of changes, how these changes will affect your organization and your Business Associates, new penalties and enforcement of HIPAA.

This 90-minute webinar on workplace social networking will cover legal concerns for HR professionals arising out of employees posting inappropriate content on social networking sites, and in using social media for conducting background checks.

The following is a pack of 3 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO requirements.