Facilities Web-based Seminars

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...orporating the changes into how they do business in their facilities. Areas Covered In the Session: The new regulations will be reviewed and their effects on usual practices will be discussed, as well as what policies need to be changed and how. We will show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. Now that there is a legislative  more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while  more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing.  more...

Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ... Design * Similarities and Differences-Equipment and Facilities * Similarities and Differences-Supplier and Component Consistency * Protocol Approval Process for Installation & Operational Qualification and Process Validation * Executing the Protocols * Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report * Revalidation Who Will  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...he Project Validation Plan * Product and Process / / Facilities / Equipment Software V&V * When and How to Use DQ, IQ, OQ, PQ (or their equivalents) * GAMP / Other Considerations * The FDA's 11 Key V&V Documentation Elements * "White Box" and "Black Box" Validations Who will benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements *  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...sponsible for conducting GMP audits at your manufacturing facilities. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval Inspections * Overview of the pre-approval inspection process * Preparation in the months preceding the inspection *  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed Rule that would amend its regulations  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 Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...g. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The impact of USP on analytical  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...entation and Records Module 4: Design Control Module 5: Facilities, Equipment & Environment Module 6: Material a Purchasing Controls-Specification, Qualification and Control of Suppliers, and controlling incoming materials Module 7: Technical and "Administrative" Process Controls Module 8: Introduction to Deviations & Quality Failures (0: 10) Module 9: Validation Module 10: Maintaining  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...orporating the changes into how they do business in their facilities. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. In addition, there are new kinds of businesses that are considered to be business associates, such as Health Information Exchanges and e-Prescribing Gateways, but also  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...r responsibilities * Understand the impact with user facilities and patient issues Who Will Benefit: This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include: * All levels of management and departmental representatives and those who desire a better understanding or a "refresh"  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...