Complianceonline

Harshit

Hi, Our website is www.complianceonline.com - one of the largest training portals in the USA and Europe for the past 10 years. We organize industry expert-driven training seminars / webinars for all industries. Our Trainings are meant for : All Corporate Decision makers (CEOs, CTOs, CMOs, All purchase managers, all department heads ) Risk management officers Process engineers Quality officers/assurance managers Documentation/Records department officials Financial officers and all related to risk and compliance in companies. HR Managers OSHA compliance officers /managers. Business Development Professionals Consultants

Offerings

Showing 1-25 of 1075 results

  • COURSES: How to Mitigate Microbials in Purified Water and WFI Water Systems: Theory and Practical Application Details Thoroughly Explained Clearly and Concisel

    This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations. Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise.

  • COURSES: Method Development and Validation for Assays Supporting Testing of Biologics:2-Day In-Person Seminar

    Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation Who will Benefit: Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar: Validation Scientists QA/QC Regulatory Affairs Laboratory Managers Assay Development Specialists Statistician CMC Titles Bio Assay

  • COURSES: Risk Management in Medical Devices Industry:2-Day In-Person Seminar

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations. By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

  • COURSES: FDA Audit, Quality Assurance Practices, Responsibilities and Expectations:2 days in-person Seminar

    It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.

  • COURSES: Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11:2-Day In-Person Seminar

    The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.

  • COURSES: Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

    Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.

  • COURSES: Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

    Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

  • COURSES: Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers:2-Day In-Person Seminar

    This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.

  • COURSES: Implementing UDI (Unique Device Identification) - Plan Now for Success:One Day In-Person Seminar

    The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID

  • COURSES: Biostatistics for the Non-Statistician: 2-Day In-Person Seminar

    Who will Benefit: Persons working in the medical or health sciences, pharmaceutical and or nutriceutical industries, clinical trials, clinical research, and clinical research organizations, physicians, medical students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports. Physicians Clinical Research Associates Clinical Project Managers/Leaders Sponsors Regulatory Professionals who use statistical concepts/terminology in reporting Medical Writers who need to interpret statistical reports Clinical research organizations, hospitals, researchers in health and biotech fields.

  • COURSES: Clinical Data Management (FDA E6 GCP Guidelines)

    Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection CDISC/CDASH/STDM standards Responsibilities of personnel Case report form criteria Maintaining confidentiality of data Data storage and transferability Data preparation and quality assurance for accuracy Data monitoring plan criteria Data systems validation Adverse event reporting and coding criteria What to expect on a monitoring visit Troubleshooting and resolution of deviations from plan Who will Benefit: Study Investigators Data managers Data processors Statisticians Site Personnel Clinical Research Associates Clinical Project Managers/Leaders Study Sponsors Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management Staff in the above fields who work with data collection/management and require training in CDM. Compliance auditors and regulatory professionals who require a knowledge of CDM in asse

  • COURSES: REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance: 2-Day In-Person Seminar

    Who will Benefit: This seminar will provide valuable assistance to all personnel in: Automotive, Electronics, Medical devices, Chemical, Toys, Industrial machinery Manufacturing Professionals Anyone new to RoHS and or REACH and need to understand the regulations. Anyone responsible for RoHS and REACH compliance. Quality Managers, Environmental Managers, Purchasers, Buyers.

  • COURSES: Aseptic Processing Overview and Validation :2-Day In-Person Seminar

    This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

  • COURSES: Packaging and Labeling in Pharmaceutical Production :2-Day In-Person Seminar

    Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.

  • COURSES: PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

    The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

  • COURSES: Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

  • COURSES: Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation

    The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

  • COURSES: Biocompatibility Testing for Medical Devices : One and a Half Day In-Person Seminar

    The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

  • COURSES: Account Payable Best Practices : One and a Half Day In-Person Seminar

    The accounts payable function is changing at a dizzying pace. Technology, new frauds and regulatory changes are all taking their toll. What worked yesterday may not work today. Given the current business environment, mounting regulatory pressures, and the increased visibility and importance of the accounts payable function, best practices are something with which every professional needs to be conversant. Unfortunately, keeping up to speed these days can be like herding cats. While some best practices remain steadfast, others simply no longer work and are being replaced by new practices just now appearing. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

  • COURSES: Expense Reporting Best Practices :One and a Half Day In-Person Seminar

    With companies everywhere eyeing the bottom line, insistence on compliance with travel & entertainment policy is becoming more commonplace. What's more, the IRS has also been taking an equally harsh stance, so compliance must now not only be to the company policies but also IRS rules. Otherwise, you could end up answering not only to the CFO but also the IRS–and that is truly ugly.

  • COURSES: Associate in Human Resources Generalist Certificate Program :2-Day In-Person Seminar

    Join us In-Person in Greenville, SC or Online via Live Stream / Webinar for our Instructor-Led 2-Day Associate in Human Resources Generalist Certificate Program. This course not only provides you with the training and knowledge you need to become an effective HR Generalist but also prepares you for the aPHR Exam! We meet from 10am to 5pm EDT Monday June 24th, 2019 and June 25th, 2019. If you are registering to participate Online Via Live Stream / Webinar then the training materials will be shipped to you and you will receive an email with the information you need to login to the Live Webinar once you register. For everyone else joining us Live you will receive your training materials when you arrive at the training.

  • COURSES: Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

    Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

  • COURSES: Statistical Process and Quality Control : 2-Day In-Person Seminar

    The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.

  • COURSES: Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR : 2-Day In-Person Seminar

    This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

  • COURSES: CA HR 101 - HR Generalists and CA Supervisors Too : 2-Day In-Person Seminar

    It is not just compliance risk management that is important. Just as important is that Supervisors need to know how to hire, coach, delegate, train and develop employees. Hiring is the most important activity of both HR and Supervisors. Coaching and delegation are as close to being “superpowers” as Supervisors ever will have. Supervisors need to know how to deal with everyday squabbles, as well as bigger problems such as resistance to change. Because when Supervisors effectively handle employees’ problems it is not just a risk management strategy it’s also a powerful employee retention tool. Attend this seminar to get comprehensive knowledge on California compliance employment problems, discrimination and harassment, leave in CA (CFRA, FMLA, pregnancy leave), and different acts like Pregnancy Disability Leave (PDL), California Family Rights Act (CFRA), Family Medical Leave Act (FMLA), California New Parent Leave Act. It will also cover hiring best practices and compliance, performance

Vendor Details

2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
Palo Alto, CA 94303
US
6502389751

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