This compliance training search contains list of all the Compliance courses scheduled as Live Webinars or available as Webinar recording links and CDs. The training catalogue features – course topics, short description, instructor's name, industry category, training level, available training option type (Live date, Rec, CD) and price.
Currently ComplianceOnline has over 700 courses across 25 industry areas. Please find/search the training/Webinars by industry category or by keyword and filter the courses by Basic, Intermediate and Advanced level. Select the trainings of your choice and add to cart, discount is available and gets reflected in cart for multiple training purchases. For bulk ordering contact customer care at +650-620-3937 or email to editor@complianceonline.com
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Note – OnDemand Recording and CD of scheduled Live webinar trainings will be available after completion of the live webinars.
This Food Safety system webinar will discuss how the current traceability capabilities, costs and trends will become integrated into food safety systems and explore the different approaches like Barcode, RFID, Manual systems, simple tagging etc.
Key validation characteristics of HPLC methods mandated according to cGMP and ICH guidelines and the stress studies must be considered for HPLC method used in pharma Labs.
This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.
This EO sterilization training will discuss the Cycle validation and other requirements for Implementation of parametric release in EO sterilization as per EN/ISO 11135.
This Out-of-Specification Investigations webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization.
Technical details need to know about the disinfectant qualification study, data review, how to evaluate log reductions, how to use study data for routine clean room cleaning operations.
This Radiation sterilization will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
This 21 CFR Part 11 training will provide types of audit trails and Strategies of implementing compliant audit trails as per 21 CFR Part 11 regulations.
This Webinar will discuss how to develop SOPs with principles and skills to ensure the SOPs are simply the result of a well defined and sound processes and also meets FDA or ISO requirements.
This Webinar presents a best practices approach to planning and executing a successful Pre-IDE Meeting with FDA. The speaker is a former CDRH Division of Cardiovascular Devices (DCD) Acting Deputy Director and Branch Chief who has significant insights into the critical factors which lead to a successful Pre-IDE interaction with FDA. The session will discuss and provide specific recommendations on how to prepare a high quality and focused Pre-IDE Submission followed by planning for a successful and interactive Pre-IDE Meeting with the FDA review team.
Various areas of people management that influence retention, identify retention efforts that can be implemented and demonstrate how to measure the success of your retention efforts.
This OSHA webinar will specifically evaluate the topic from the viewpoint of a California facility identifying and explaining requirements of the California Fire and Building Codes as well as California OSHA.
This training on Statistical Analysis for clinical study will teach attendees how to create and review a Statistical Analysis Plan. The key components will be described in a language understandable both to statisticians and non-statisticians.
Understand what is the CER and how to prepare for and defend it and properly constructing a "bullet-proof Technical File and manage your documentation.
This Medical Device Risk Management Standard training will guide you through ISO 14971 standard review and exploration of the risk management process, requirements of ISO 14971 and how to implement it, Highlighting of various standards like IEC 60601-1,ISO 10993-1 and upcoming ISO 14155.
This Food cGMP's 101 webinar/training will review the cGMP's using real-life examples to help you understand the expectations and benefits of operating under an effective Quality System , as well as a discussion as to the ramifications of not following cGMP's.
This Regulatory Requirements webinar on Medical Device Calibration defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts, the webinar moves to an analysis of FDA requirements and ISO 13485 requirements.
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.
This cGMP training will helps you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
This HR Compliance training will help you navigate through the difficult times we are currently in. You’ll learn how to reconnect with your employees at a time when they are experiencing insecurity and dips in motivation. You will learn how to help them deal with “survivor’s guilt” and feel empowered to ask the right questions at the right time.
This 21 CFR Part 11 training will help you in Auditing for Part 11 Compliance ,how to plan, prepare, execute and close audit, what tools can be used for a successful audit.
This ISO 13485:2003 Webinar will discuss the differences of ISO13485:2003 and ISO 9001:2008 and FDA requirements. Which SOP’s are necessary to implement an ISO 13485:2003 Quality Management System and use of harmonized standards.
This webinar will give technical communicators with an insight into the requirements of ISO\IEC 26514. It provides organizations guidance on meeting an internationally recognized standard when developing user documentation.
This Process Validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
This IFRS (International Financial Reporting Standards) training will help acquainted with the latest information regarding IFRS for SME’s and will include an opportunity to practice applying these standards.
This EO Sterilization training will help you in understanding how EO sterilization works, the equipment involved, major issues with product sterilization via EO, and the validation requirements. Routine process control and monitoring.
Discussion will be on discipline policies, standards of conduct, the process of counseling and progressive discipline, up to and including terminations, objectives of discipline, the reasons for substandard performance, investigating circumstances and documenting discipline, the difference between counseling and coaching, and determining when termination is recommended. It also will cover legal aspects of discipline and discharge.
Learn about different inspections and testings and their applications as well as methods, errors, software verification and professional/technical terms and definitions.
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
In this GMP auditor training for pharmaceutical companies you will learn what a GMP auditor should do and how to conduct an audit. An overview of various GMP regulations and discussion on most commonly cited GMP violations and how to find and correct it.
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.
Requirements for DQ, IQ, OQ and PQ as per USP <1058> will be discussed in detail with recent inspection trends related to equipment program and practical means to prevent such deficiencies.
In this GxP (GLP, GCP, GMP) Computer Validation training you will learn successful process of GXP computer systems validation and the essential elements must be addressed and delivered for scalable and risk based computer validation project.
This ISO 14971:2007and CE-Mark training will help in understanding the elements of your product risk management file and how to comply with ISO 14971 or ICH Q9.
This Validation training on Analytical methods will give specific recommendations on how to plan, conduct and document analytical method validation for efficient FDA, USP and ISO 17025 Compliance.
This Clinical training will guide you through Enhanced techniques to optimize productivity without compromising subject safety and quality data in clinical monitoring for US- based premarket trials.
In this Ethylene Oxide (EO) Sterilization training learn how to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance.
This Master Validation Planning training will evaluate how to do Validation and Verification under the current changes came due to the March 2010 Mod 5 changes to the EU MDD.
In this FDA clinical trial training get guidance and learn to interpret various clinical trial requirements and regulations. The general scientific principles for the conduct, performance and control of clinical trials will be examined.
This medical device training on International Standards will address various sources of external standards, how they are developed and the differences from region to region.
This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.
This potency bioassays training will helps you in understanding how to design assays to measure potency, key validation parameters, specifications, Case studies stating problems due to method variability and impact on accuracy of potency measurements.
This Clinical Trials Regulations in Latin America training will review the applicable Regulatory Process in the main Latin American countries where Clinical Research is developed, identifying opportunities to speed protocol approval in these countries.
In this GxP (GLP, GCP, and GMP) Computer Validation training you will learn strategies and tools to identify, gather, categorize, prioritize, and document for creation of a successful and robust user requirements document which is essential for successful computer system validation.
In this HR training you will learn how to avoid some of the traps that can hurt you and your organization as you navigate change. Learn how to avoid nasty disciplinary actions that could lead to difficult legal problems. With a positive approach to change, you will be able to prepare your employees to deal with new situations and gain more confidence more quickly. A satisfied workforce leads to increased productivity and decreased liability.
This presentation will detail the expectations and the details of the new GHTF guidance document on “the Controls of Products and Services Obtained from Suppliers” published in December 2008 and also discuss how these new requirements affect suppliers and what suppliers need to do to be ready for further evaluations and audits that their customers will be conducting in the future. It will also focus on how design and development, risk management and process controls are intricately linked to purchasing controls.
This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations.
This GxP (GLP, GCP, GMP) Computer Validation training will discuss on insights and tools for creating successful Change Control and Periodic Review processes in order to help ensure that a GxP computer system remains in a controlled state beginning with validation activities and extending through the life of the system.
This Business Risk Mgmt training will guide you on ISO 31000 general risk management standard, the process model it recommends, and how companies may use the standard, and its companion risk assessment tools document ISO/IEC 31010.
