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This IFRS training will discuss the procedure of implementing International Financial Reporting Standards and the factors companies should consider in implementation.
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 “Advanced Process Auditing Course” teaches the principles and practices of effective quality systems and process audits in accordance with ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.”
This presentation will review the current state of maturity models and prepare you with a roadmap for successfully enhancing your current process or building a strategic plan for GRC excellence.
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 supplier qualification training/Webinar will discuss on strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and how to detecting fraud.
Detailed review of the components of ICH, OECD and other key regulatory guidances as they relate to drug safety, quality and efficacy for global submissions. The specific data sets and timing of studies needed at each stage of drug development process will be presented and discussed.
This Risk Management Webinar/training will discuss how to use the 5 different tools which should be used in risk management process as per ISO 14971. It also emphasize on the documentation of results of the usage of tools.
This Clinical Trials and GCP session will describe the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.
This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.
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 Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.
This webinar will help companies that are currently setting up a microbiology laboratory as well as current microbiology laboratories to evaluate themselves against the current practices.
How to implement Rapid Microbiological Methods to detect, quantify and identify the microorganisms in products, processes and manufacturing environments. How to evaluate RMMs and deploy it in labs and manufacturing areas.
This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.
The Risk Management training/webinar module will describe the financial considerations involved in the emergency management planning and implementation process.
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 contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.
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.
Why HR metrics are important to an organization, how they assist with the decision making process and how they are used to align people performance with organizational goals.
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 Clinical Trial training will review the current status of Clinical Trials activity in Latin America, the factors that make this an attractive region and some best practices to ensure a successful implementation of clinical trials.
This Microbiological Foodborne Webinar will highlight how to manage the different type of foodborne threat and reduce the risk of food borne illness outbreak.
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.
In this Water System Webinar T. C. Soli will explain the process of solving water system problem or product contaminated with water-type organism through real life case studies which were adopted successfully by various companies. Though there is no rule book or SOP for water system contamination problem solving, learn the best practices of solving these problems.
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 EU Medical Device Directive (MDD) training will guide you through changes to the Medical Device Directive 93/42/EEC, by the M5 Directive 2007/47/EC and its effect on CE mark and steps to comply.
The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.
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 training will highlight key toxicity issues that should be followed up through mechanistic/investigative studies, define the current best practices in these key areas and define what the regulatory agencies want to see in terms of mechanistic/investigative follow-up and safety biomarker and the defined regulatory path in terms of data submissions.
This course aims to provide expertise in the use of EDC and EHR during the development of clinical practice, and describe solutions on how to optimize and ensure the quality of data recorded on the achievement of balance of Pharmaceutical Industries and local expectations of study and the limitations to the current requirements Application for Marketing and always following the GCP guidelines.
In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them.
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.
This HR compliance training will cover auditing human resources practices for compliance and liability to help identify and correct any areas that may not comply with applicable laws and/or do not comply with company policy.
This Webinar will discuss the modalities of proper investigations for environmental excursions and how to find the root cause and take appropriate preventive actions.
This Webinar will discuss how a requirement management approach consistent with the CMMi Requirements Management KPA, helps companies meet Design Control requirements
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 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 Evaluating Clinical Sites training will review the process of Site Selection focusing on current challenges to obtain valuable information that will better predict the success of a clinical site.
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.
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 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.
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 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.
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.
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.
This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations.
This Food cGMP's 101 webinar/training will review the cGMP's using examples as to how to meet the requirements effectively, as well as a discussion as to the ramifications of not following cGMP's.
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.
The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities.
This Proficiency testing (PT) training/webinar for CLIA will explain the rules of PT testing, the PT testing "danger zones", and CLIA's stance on PT referral and also gives tips and techniques to assure good PT performance.
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.
This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods.
This IFRS Webinar will give the latest information regarding IFRS and will include exercises in designing and implementing controls for IFRS processes.
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 Food Safety Webinar/training will discuss the steps can be taken to reduce the risk associated with a food safety outbreak or recall. How to use different systems and models to assess the risk and reduce it.
This webinar will provide valuable tips to do supplier qualification and assessment at less cost and time and also be in control of the suppliers along with be compliant with QSR and ISO requirements.
Discussion on processes and effects of immunogenicity, screening methodologies to measure immune response, how to apply regulatory mandates and what are commercial repercussions of unwanted immune responses.
In this Clinical Statistics webinar/training all topics will be taught from a practical, non-theoretical perspective for non-statisticians & value and meaning of descriptive statistics including the use of normal vs. non-normal statistics.
This Webinar/training will discuss how companies can adopt the Voice of the Customer (VOC) process in product development to meet the standards of Comparative Effectiveness Research (CER).
This food allergen Webinar training will discuss the technologies and practices that enhance an allergen program and its supporting program like GMP, HACCP and sanitation.
This FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.
This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.
This webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their processes to effectively implement the requirements of the regulations.
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 Clinical trial auditing webinar will discuss on components of a good audit program, identify effective CAPA, review 483 examples, warning letters and worst case scenarios.
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.
Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.
This Risk compliance training will guide you through the new tools to streamline compliance, how to communicate the value proposition of compliance and risk management and anticipate new regulatory scrutiny and more intrusive audit engagements.
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 Allergen Control webinar/training will Identify allergens in raw materials and provide an brief overview of best practices for labeling allergens.
This course is designed to provide a detailed overview of the role of toxicology in Drug Development. Participants will obtain an overall understanding of the principles of non-clinical safety evaluation with emphasis on application and interpretation of non-clinical safety data as it relates to and is integrated into the multi-disciplinary development plans and how it affects decision-making at each stage of the development process.
This program helps managers master the art and science of performance documentation. Learn how to write behavioral documentation that protects your organization while promoting better performance from employees.
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 Webinar will discuss the Marketing Authorization Processes – Filings & Registrations in Japan. How and when to influence the regulatory process and how to use regulations to your advantage.
This ISO 9001:2008 webinar explains the changes in ISO 9001:2008 related to outsourced processes. Discussion on the ISO’s guidance document on outsourced process to have an understanding of the intent and develop methods for evaluation and selection of outsourced suppliers, methods for written supplier agreements.
This Biopharmaceutical training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes.
Learn the current regulatory guidances in USP1034 chapter of analyzing bioassays, and USP1033 chapter of bioassay validation and know how to take the potency bioassay from pre-clinical development throughout final commercial implementation.
This Standard Operating Procedures (SOPs) webinar training will give basic understanding of SOPs, and how to write and maintain SOPs for areas requiring SOPs as per ICH and new Medical Device Directive 2007/47/EC.
This CAPA and Risk Management Webinar/training will discuss the multi-level CAPA process and how regulatory standards requirement for CAPA relates to risk management.
This Pediatric Clinical Trial Design training explains the regulatory requirements for conducting clinical research in the pediatric population, the ethical considerations around the development of pediatric trials, and the challenges of research in this vulnerable population.
This Audit Webinar/training will discuss how to create an Internal Audit Opinion as per 2009 issued IIA Guidance on "Formulating and Expressing Internal Audit Opinions" which Internal Auditors presented to board, management and other stakeholders.
This Webinar will discuss the overall regulatory compliance requirements ( pre-clinical, clinical, utilization of ICH standards, Regulatory filings, registrations etc.) in Japan for Life science products. Discussion on how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution.
This Laboratory Investigation training will provide guidance on procedures investigating unexpected results for Non-Clinical and Clinical Trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.
This Webinar/training will review the best practices for setting environmental monitoring limits and items to be included in an investigation to determine a limit excursion for viable and non-viable excursions.
This 510(k) and risk management webinar /training will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstration the product is safe.
This adverse event reporting Webinar/training will discuss the clinical trial regulations requirements with respect to adverse event and explain how to assess and report AEs and SAEs.
This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.
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 Viral Safety training/webinar will discuss the criteria and scope of viral safety studies needed prior and during clinical development as stated in new EMEA guidance document.
This Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation.
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.
In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. As applied to the overall Design Controls process phases, will be presented.
A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.
This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.
This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.
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 food safety Webinar training will discuss NLEA regulations and the elements which need to be taken care for retail and food service labeling to ensure product.
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
This supplier management webinar training will discuss the QSR and ISO requirements for supplier evaluation and assessment along with teach how to do supplier related corrective action.
This Microbiology testing Lab design training webinar will discuss the comprehensive design strategies in accordance to FDA, ICH, CDC mandates so as to ensure successful audit of quality compliance and bio hazard protection.
This Sterile manufacturing webinar will review the regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry, design and construction features, including materials for construction and facility operational flow diagrams and layouts.
This performance appraisal training/Webinar helps managers master the performance appraisal process from start to finish. Learn how to avoid legal landmines, as well as, build rapport with employees while helping enhance performance.
This Financial Risk Management webinar will teach attendees how to do basic computation of at-risk enterprise cost and how to relate cost to potential loss.
This change control webinar training will provide essential compliance information on current regulatory standards under 21 C.F.R. and FDA’s Guidance Documents and Draft Guidance Documents for managing DMFs and associated Change Control effects and implementation strategies.
This OSHA webinar will discuss the safe usage and storage of flammable liquids used in lab and pharma companies as per California Fire and Building Codes and California OSHA.
This COSO 2009 Monitoring Guidance training will discuss the concepts offered in the three volumes proposed in New 2009 COSO Gudiance for intended to promote monitoring program.
This Supplier management training webinar discusses how to control products and services from suppliers as per Global Harmonization Task Force (GHTF) guidance document. Also requirements for managing suppliers and the reasons for these requirements.
This Product Risk Management webinar provides 5 steps for medical device managers from Quality, Marketing, Manufacturing and R&D to drive the success rate of the VOC product development process, in a milestone/checklist process to provide guidance on how to direct product development teams through manageable, avoidable and expensive pitfalls.
This CAPA webinar will teach development and implementation of a corrective action plan and suggest how to verify effectiveness of corrective action so as to prevent occurrences instead of re-occurrences.
This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation.
This Microgranules training/webinar will discuss all common variables involving pharmaceutical pellet development and manufacture using different manufacturing equipment.
This environmental training will present a macro overview of the apparent 180 degree turn between the current and past administration on environmental issues, and related topics.
This water systems compliance webinar training will discuss the myths surrounding microbial monitoring and control approaches and guide you know the correct way of handling it.
This Ethylene Oxide Sterilization training will discuss the implementation approach for parametric release in EO sterilization as per EN/ISO 11135 guidances.
This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.
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 Food Safety Crisis Management training / webinar will discuss how to develop and effective crisis management program to tackle product recovery and product recall effectively.
This Risk Management training will discuss how to develop a compliant risk management process as a part of medical device Quality System built as per ISO 14971 standards.
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.
In this In house laboratory training we will discuss the best methods for analyzing your needs, space, test methods and reimbursement & the rules and regulations mandated by CLIA for In House testing.
This Environmental compliance training will guide you through the current situation associated with the environmental regulatory framework and the compliance market for renewable energy.
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 webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization.
This Quality management training will guide you Implement Risk Management Principles and Activities within a Quality Management System & ISO-based Quality Management System Reviews.
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 Medical Device Regulatory training will review changes to regulations including the European Union Medical Device Directive and also discuss changes to international standards, which will also impact the medical device industry.
This Contamination control program training will teach how to develop and document an integrated program to reduce the potential of foreign material contamination and also highlight the GMP best practices.
This Dry Powder Inhalers training session on future pulmonary delivery will give you a clear orientation for your actual or future developments in this area in terms of formulation and product and new product launching possibilities.
This webinar provides a thorough demonstration of what information can be extracted from a surface swab recovery study for maximum leverage in a cleaning and cleaning validation program.
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 statistical analytical plan webinar training will guide the attendees how to create a SAP and showcase the essential elements of it and how to create as per the expectations of regulatory bodies.
This Advanced CAPA training webinar will teach how to evaluate CAPA system for compliance along with highlight the common problems and likely system failure sources and how to proactively address these by various methods like internal audits, GAP analysis.
This cGMP's webinar/training beyond CFR110 will provide valuable information to food manufacturing companies, especially those who are not certified to ISO: 9001.
This COSO training will provide an overview of the materials available from ISACA (Information Systems Audit and Control Association) which are key to building a set of comprehensive General IT Controls to meet SOX requirements.
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 ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.
This Disposable Technologies training webinar in GMP Facility will guide you through the practical aspects of implementing disposable technologies and offer superb control of process stream contaminants such as endotoxins and bioburdens.
This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.
This COSO webinars (2 modules) will discuss on the new 2009 COSO Guidance for Monitoring issued recently to promote more effective monitoring program for public companies.
This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.
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 Medical device training will be highlighting the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
This OSHA training/webinar will review the Multi-Employer Citation Policy in-depth, applicable case law, and present recommendations for avoiding citation by OSHA and state regulatory agencies.
This Microbiological Risk webinar will present reasons why it's in the best interest of a company to test their raw materials: not only from a regulatory perspective but also from a safety and sound business perspective.
This Out-of-Specification Investigations (OOS) training/webinar will guide you through initial laboratory investigation which follows the FDA guidance; Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
This CAPA webinar provides a clear and simple explanation of corrective action and preventive action systems. It cuts through the confusion by explaining the technical definitions of correction, corrective action, and preventive action.
This Post Market Surveillance training/webinar will discuss how the Postmarket initiative of FDA impact your company and how to keep ahead of potential problems by knowing common , but avoidable mistakes and examination of some recent warning letters to know how the FDA views complaint handling, reporting and recalls.
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 webinar will provide valuable assistance to all healthcare organizations and institutions; architecture and construction management companies; infection control practitioners and industrial hygienists; joint commission verifiers and reviewers, and construction companies engaged in healthcare construction projects.
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 Design Control training will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.
This Clinical Research training will guide you on Secret of Study Conduct Documentation to ensure a successful Audit and what FDA inspectors looks for.
This Structured Product Labeling (SPL) webinar will provide valuable assistance and a road map to device companies who need to learn how to properly create product and patient labeling information and meet minimum compliance expectations.
This Clinical Study Report webinar/training is designed to provide guidance for producing such a document, included are the outline format, concepts, guidance for text, and guidance for the appendices.
This COSO Monitoring Guidance webinar/training will cover the overview of why this guidance was issued, what the benefits offered by COSO in this new 2009 Guidance and Will demonstrate practical tips you can leverage today to lower your SOX compliance costs.
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 510(k) Submission Webinar will provide a unique opportunity for the participants to create a Traditional 510(k) application and ensure that proper formatting and content are used prior to submitting to FDA.
This Clinical research training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product research involving human subjects.
This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
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.
