Approved Web-based Seminars

Health Information Technology Introduction ...urs long. These sessions along with certification from an approved certification center will prepare you for a career in Health Information Technology. HCMI Solutions Internship opportunities are available upon completion of the sessions below and registration in an approved Health Information Technology Certification program. Contact us for additional information on the HCMI Internship  more...

Health Information Technology Systems ...urs long. These sessions along with certification from an approved certification center will prepare you for a career in Health Information Technology. HCMI Solutions Internship opportunities are available upon completion of the sessions below and registration in an approved Health Information Technology Certification program. Contact us for additional information on the HCMI Internship  more...

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel ...isseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e. g., social media or other public electronic media). In  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements - Webinar GlobalCompliancePanel Overview: Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Thursday, May 17, 2012 10: 00 AM PDT | 01: 00 PM  more...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background  more...

RAPS Approved Seminar on Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary  more...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary  more...

RAPS Approved Seminar on Risk Management in Medical Devices Industry at Mumbai Overview: The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management  more...

RAPS Approved Seminar on Risk Management in Pharmaceutical Industry at Mumbai Overview: This training course has been designed to address the processes, methods, and tools associated with Quality Risk Management. It highlights the disciplined environment that is necessary for proactive decision making to continuously assess what risks a organization is exposed to, which risks are important to deal with and how the implementation of strategies can mitigate risks.  more...

RAPS Approved Seminar on Complying with GMP and CGMP Requirements Streamlining Quality Assurance and FDA Compliance at Mumbai Overview: Each lecture will be 90 min in length. There will be morning and afternoon breaks of 30 min each which will be reduced to 15 min, if needed to accommodate long lectures. Lunch will be at least 1 hr in length. The instructor will be available for questions and discussions during all breaks and lunches and will also be available for a minimum of 30 min at the end of each day. The  more...

FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion What is Acceptable or Not Acceptable - Webinar By Gl Overview: This webinar is intended to discuss the best practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). Wednesday, March 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...w: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ue if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/ or which local inspectorate is responsible for conducting GMP audits at your  more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina ...l to market a device for the purpose that it has not been approved for by the FDA. This webinar provides guidelines set by the FDA for off-label promotion. Areas Covered In the Seminar: * Off-label statute * Label claims * Allowable reprints * Promotional compliance * FDCA: The law Who will benefit: * Sales executives in Medical Device * Regulatory  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...uirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain "approved." You never have to pay a visit to your supplier if you have a great supplier control program in place. Areas Covered In the Seminar: * How to qualify new suppliers in a  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible for large  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...tive Action. However if the spreadsheet is not validated, approved, and documented properly it may create a problem during an FDA inspection. An unvalidated spreadsheet violates the QSR requirements for automated processes. The next easy step is to eliminate the form used in the manual calculation. It would straightforward, as the next step, to reduce the paperwork and just keep the  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ..., clarify that a manufacturer can make unilateral pre-FDA approved labeling changes "only to reflect newly acquired information" when there is "reasonable evidence of a causal association" between the drug or device and the risk. The final rule defines "newly acquired information" as "information not previously submitted to [the] FDA." This includes a new analyses of previously submitted  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel ...discussed, as only it can be by this actual author of the approved guidance. There are many consultants and "experts" that teach this subject, but almost none have first-hand knowledge of its development. Some of the behind the scenes background will be discussed so that participants will be able to better understand the true intent of the expert work group's negotiations. What are some key  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ...s of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements ...sions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products that emit radiation that are imported into the United States must comply with applicable U. S. regulations before, during, and after importing  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

Multifamily Building Modeling for Weatherization ...s of multifamily energy modeling using DOE weatherization approved audit tools. It will include a systematic approach to improvement-driven modeling in multifamily buildings - with plenty of opportunity to get all your questions answered by some of the leading experts in the industry. Performance Systems has extensive experience in multifamily housing, including the improvement of over 10,  more...