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This Quality by Design (QbD) webinar training will discuss what the agency is looking for and how to build a relationship with regulators by following certain dos and don’ts.
This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.
This Complaint Handling Live training/webinar will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm’s CAPA program.
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).
This Disinfection and Cleanroom Cleaning training will teach you how to choose correct disinfectants, know what disinfectants do and what not, methods to qualify disinfectants, writing and executing cleaning procedures.
This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.
This Webinar will discuss how a requirement management approach consistent with the CMMi Requirements Management KPA, helps companies meet Design Control requirements
This Webinar will discuss, the Pre-IDE Meetings – benefits, cost, time lines, agenda, schedule, participants, recommendation and how to prepare for a high quality Pre-IDE submission with cases of Pre-IDE meetings such as Prototype has been evaluated in preliminary animal study(ies), Feasibility Study completed (or nearly so) etc.
A detailed understanding of calibration and qualification of lab equipments, development of qualification master plan, allocation of equipments to qualification categories A, B, C, the approach for existing system qualification.
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
This excel spreadsheet compliance training/webinar will help in identifying the critical spreadsheets, structured approach to manage it and how to put controls to protect it.
This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations.
Discussion on FDA’s new focus during inspection of computer systems and e-records, reasons for deviations and how to write CAPA plans to avoid 483 and respond to 483’s to avoid warning letters.
This FDA's Update on Draft Guidance webinar will provide an overview to companies who need to learn how FDA evaluates risk communication in promotional materials and what factors are considered for Drug and Device Promotion.
This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.
This OOS Webinar training will discuss how to handle OOS situations, requirements of ICHQ7A for APIs and how to develop CAPA plans, how to use checklists and forms and how to develop FDA compliant OOS documentation.
This clinical trial training/ webinar will provide guidance and interpretation of the various clinical trial requirements and regulations. The general scientific principles for the conduct, performance and control of clinical trials will be examined.
This Comparability Protocols training will provide you with the basics for utilizing the Comparability Protocol and assist in helping shorten the time for implementing pre and post approval changes.
This purchasing control Webinar/ training will discuss how to use the tools of risk management in achieving safe and effective medical devices and reduce recalls due to failure of components, device or services supplied to device manufacturers.
This Software Validation training will guide you on how to maintain compliance while downsizing with reduce costs and Increase compliance with lowering resource needs to avoid 483s warning letters.
This excel sheet validation training/ webinar will demonstrate how FDA requirements will be met through spreadsheet validation in regulated environment. How to design spreadsheets for part 11/GxP /SOS/HIPAA, document planning, specifications, installation, testing and changes.
This V & V planning Webinar/ training will discuss how to companies can re-evaluate their V & V system and related documentation to get to a compliant and new systems and procedures.
This CGP compliance Webinar will discuss the investigator role and responsibilities in clinical research process and highlight the ways to involve effectively the Principal Investigator in clinical research process.
This Ethylene Oxide Sterilization training will discuss the implementation approach for parametric release in EO sterilization as per EN/ISO 11135 guidances.
This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).
This software verification and validation training / webinar will discuss and address software verification and validation issues and their documentation to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters.
This FDA audit training 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.
This beginner level session will help companies to better understand how to improve the CAPA process and include Risk Management in review of Post-production product experience.
This FDA inspection training webinar provides practical advice on the FDA requirements for complaints. It explores the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side we explain the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints.
This Clinical Trial Audit webinar / training is designed to provide information on the importance of having an audit plan in place for clinical trials to be submitted to the FDA. Development of an independent audits/data verification and compliance monitoring program will be discussed.
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.
This contract manufacturing training will discuss GMP compliance for contract manufacturer sites with emphasis on how to control quality at a contract manufacturer site.
This webinar addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations.
This FDA cGMP training webinar will discuss US FDA’s approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate.
This Water system microbial excursions training will discuss the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort.
This UDI training will highlight the different aspects of FDA's UDI Rule is Coming in 2010 and how it will impact your company. It will also give insight in to UDI alternatives.
This webinar will provide valuable assistance to all regulated companies Information Technology practices including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields.
This webinar will provide valuable assistance to all regulated companies Information Technology practices including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields.
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.
This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.
This Water system validation training will guide you how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the validation.
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.
This Microbiology Laboratory training provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance,test failures,resolution of audit findings.
This Bioassays training/webinar will systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
This FDA Regulated Industries training/webinar will show you best method available today to make step-change improvements quality performance. Your will learn how to harness the ideas and energy of your employees for quality improvement.
In this Legal Writing webinar/training in Effective Regulatory Submissions, you will learn the writing skills that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking.
AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment.
This Design Control training/webinar will emphasize on the Quality System Inspection Technique (QSIT) which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections will be discussed Real life examples of FDA design control compliance issues will be examined.
This Computer System Validation training/webinar will review all 10 documentation templates on "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org) 2006.
This Computer Systems training/webinar will provide strategies and tools for FDA compliance change and version control of planned and unplanned changes. Attendees will receive reference documents for easy implementation.
This FDA Inspection training/webinar is designed to provide an overview of the GMP regulation and how FDA inspects a facility to assure compliance with them. Knowing this, suggestions are made to prevent FD 483 citations.
The Computer System Validation training/webinar will have an interactive discussion of user validation as required by 21 CFR Part 11 and detailed recommendations for performing efficient validation projects.
This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.
This Risk-Based Validation training for cGMP Systems will guide you through case studies for the construction qualification, relocation and new equipment installation for a cGMP facility.
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.
This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
This Internal Site auditing webinar will describe a proven process for conducting a comprehensive site audit for inspection of computerized systems and Case studies will be used.
This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.
This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.
This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such.
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI (Pre-Approval Inspection).
This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.
This FDA compliance webinar provides FDA’s current thinking on modernizing the regulation of quality and manufacturing science through establishment of a new regulatory framework.
This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.
This Internal Quality Audit webinar is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.
This healthcare webinar will give an introduction to lean in healthcare which includes an illustrative exercise to aid participants in understanding the basic underlying concept of lean.
This Technology Road Map webinar case study will provide a system for prioritizing and understand the migration of technology development over a 5 to 10 year time span.
This Viral Safety webinar will provide case study examples that demonstrate the importance of pre-validation viral clearance data for optimizing a process step to provide robust viral clearance.
This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.
This Quality risk management training/webinar will examine considerations for the expanded role of QA in drug imports, and the expanded scope of Quality Risk Management with reference to FDA Globalization Act of 2009.
This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.
This FDA compliant training for computer system will present strategies for complaint and efficient system retirement. Attendees will receive reference documents for easy implementation.
This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device.
This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act.
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.
This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment.
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation.
This Verification vs. Validation training will guide you through the risks and complications involved with the application of sound verification and validation principles.
This IEC 62304 standard implementation training will address key elements of the standard to install in your software systems and how can IEC 62304 help me answer an FDA objection related to software.
This “FDA Globalization Act” training/webinar will review the proposed legislation and guidance, the implications of each, and suggest approaches to proactive compliance in FDA Globalization Act of 2009.
This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training.
This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.
This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing.
This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits.
In this FDA inspection training you will understand the key policies and procedures that must be included in your SOP and how to properly manage FDA investigations for the best outcome.
This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.
This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.
This medical device training will provide insights to the background of the revision, how it has developed that is important for compliance professionals to understand then summaries what is in it and what this means to medical device manufacturers.
This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.
This Pharmaceutical training will review the value that pharmacy claims data offers in the identification and tracking of many of these regulatory guidelines and accreditation standards.
This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.
This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.
In this design Input training we will define design input, review robust requirements development, assess the impact of user needs vs. patient needs and discuss options for timing your design reviews.
In this Quality Risk Management training develop and implement a policy for a Quality Risk Management Program and determine how to select the direct-impact systems and processes to apply your policy - formal QRM.
The seminar will address the compilation of Marketing Authorisation applications in the EU in accordance with the Common Technical Dossier (CTD) format.
This Training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
In this OOS (Out of Specification) training guidance will be provided in developing assays that will meet specifications thus reducing OOS and OOT results.
This will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner.
This Hazard Analysis training will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts.
This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations.
In this FDA compliance training will discuss the important tips on how to respond to both 483s and Warning Letters in an effective way and how to avoid common pitfalls.
In this Sterilization training will review these requirements and practices for gamma and electron beam irradiation in a practical manner so the product manufacturer can better understand the application of the ANSI/AAMI/ISO 11137 and AAMI TIR 27.
This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high.
This HPLC (high performance liquid chromatography) training will cover the beginnings of HPLC through method validation and method development. Attention will be paid to understanding the thought process behind HPLC methods in the laboratory.
This FDA compliance training will cover the basics of using Word styles and describe the fundamentals of Word styles, including character, paragraph, list and table styles.
This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.
In this Medical device training will show you how to make the DFMEA process work for you. How to use the process to help focus your testing matrix to target the most critical aspects of the product's design and function.
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.
This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.
This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.
This Drug Labeling training will provide valuable assistance to those individuals who will be involved in the preparation of prescription drug labeling for new NDA submissions.
This Good documentation training is intended to introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.
This FDA compliance training will guide attendees through the entire process from establishing trainings, through developing and implementing training plans to FDA compliant documentation of effectiveness.
This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.
This OOS (out of specification) training will guide you through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
This Quality Management System training will discuss how to choose an advanced and comprehensive system for quality and compliance management to meet the unique needs of the FDA-regulated environment.
This Regulated compliance training will provide detailed guidance in the development of policies and procedures that are both effective and user-friendly for people with limited writing experience.
This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches
Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry.
This document control system training will review FDA and ISO requirements for document control and also offers a cost-effective, time-saving alternative to a typical document control system.
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
This FDA Compliance training will be helped to see how to develop, maintain and improve on a compliant CGMP Employee Training Program for their particular company, product line, and culture.
This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.
In this General manufacturing training we will discuss Regulatory facility design considerations with guidelines and standards for successful facility design.
This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.
This CAPA training will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system.
This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address.
This FDA compliance training will describe the essential requirements for producing sterile products in a practical, clear, concise manner that will facilitate its implementation.
This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines.
This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner.
Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.
Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.
This webinar will provide valuable assistance to all companies that utilize computerized systems to generate, process, and maintain regulated information as part of a clinical investigation.
The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6.
This webinar will provide valuable assistance to all regulated companies that need to commission and validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented?
The U.S. FDA has issued the final rule establishing regulations requiring current good manufacturing practices (CGMPs) for dietary supplements / nutraceuticals.
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.
This seminar explains how to develop a change control plan that satisfies all parties with minimal documentation. It provides proven techniques for categorizing and processing changes so that quality is improved and overhead is reduced.
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions.
This session describes how to use testing to verify system acceptance and covers how to efficiently write and execute test cases and how to develop the testing protocol.
This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products.
This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.
