Assistance Web-based Seminars

Conducting Successful Product Complaint Investigations - Webinar GlobalCompliancePanel This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products-GCP This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ... Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/ Compliance persons. * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...)  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: * Senior Management * Project Managers * CRA Managers * QA/ Compliance persons * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...)  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ... Who Will Benefit: This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be: * Principal Investigators and sub investigators * Clinical Research Scientists (PKs,  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel Overview: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...s Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the establishment registration and  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...s Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...s Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Clinical Quality Assurance Auditors * Clinical Quality and Compliance Professionals * Clinical Research Associates (CRAs) * Project Managers * Medical Monitors * Regulatory  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...s Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include: * QC managers and personnel * QA  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  more...

Introduction to Professional Organizing - Webinar ...viduals, families and companies, large and small, welcome assistance from Professional Organizers and as our industry matures, the need for more of us that instinctively know how to turn chaos into control increases dramatically. This webinar has been created to answer the many questions that must run through your head as you explore this industry and to teach you the basics of operating an  more...

ONLINE TIBCO TRAINING IN HYDERABAD Transient IT Services, Inc is a global IT solutions provider focused on delivering customer value through high Quality Processes and Cost-efficient solutions. Transient IT Services has been one of the trendsetters in global delivery practices with our Client-Centric Model for customer management and delivery. Established in 1999, Transient has grown to over 150 employees while establishing an  more...

ONLINE JAVA TRAINING IN HYDERABAD Transient IT Services, Inc is a global IT solutions provider focused on delivering customer value through high Quality Processes and Cost-efficient solutions. Transient IT Services has been one of the trendsetters in global delivery practices with our Client-Centric Model for customer management and delivery. Established in 1999, Transient has grown to over 150 employees while establishing an  more...