Criteria Web-based Seminars

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel ...criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V process to the product and risk. Why you should attend: * Whether you're planning to audit an internal IT system, anticipating an audit from a customer, preparing for the inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...e to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product. Companies have not had methods in place to perform this activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation. Areas Covered in the Session: * Choosing the  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ... the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...ropean Pharmacopeias (USP and Ph. Eur.) * Acceptance criteria Who Will Benefit: Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/ process development: * Microbiology * Quality Control * Quality Assurance * Manufacturing * Validation * Regulatory  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...inely 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 cost efficient manner * How to assess current suppliers in a cost efficient manner * How to perform  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ... * Excel Validation o Setting the validation criteria + Data types + Using lists to keep data consistent o Developing an input message o Developing an error warning message * Using the Excel Convert Function o Changing the unit of measure * Excel Formula Auditing o Tracing precedents and  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...t or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable course for personnel to meet program training requirements. Why you should attend: Recalls for chemical contamination can be costly to an organization injuring consumers and damaging the  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ... new Part 11 program: time frame, expected outcome * Criteria for selection of target companies * What inspectors are looking for * How to prepare your company for the upcoming inspections * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations * How to fill gaps short term * Developing a program for long  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...tations for device tracking * Identify new terms and criteria * Understand the statutory criteria and what changed * FDA has issued orders to manufacturers who are required to track various implantable devices * Define the additional guidance factors to be considered when determining whether a tracking order should be issued * Understand why tracking methods are subject  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."  more...

Using SLAs to Facilitate Enterprise and IT Governance Risk Management and Compliance GRC - Webinar by GlobalCompliancePanel ...communication on risks to stakeholders * Measurement criteria on GRC actions and a basis for ongoing improvement What You will Learn from the Webinar: * Receive a clear picture of the current view of GRC * Obtain a clear knowledge of SLA concepts and how they relate to the enterprise-wide view of Service Level management (SLM) and its associated Service Level Objectives  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...compliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ...termine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of a Protocol Not Followeda (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation,  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and  more...

Complete Java Training ...ulk updates and deletes * Native SQL Queries * The Criteria API o Overview of the Criteria API o Working Querying with the Criteria API o Query by Example * Data Acess Layer Design o equals() and hashCode() o Caching and Efficiency o Design Considerations Spring Framwork Training * Spring Modules Introduction o Web Applications o Persistence Support o  more...