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Courses

  • 41 Request Info

    Compliance In Action | Fundamentals of Nondiscrimination

    Finding the time to explain or reinforce your nondiscrimination policies – and what those policies mean in the day-to-day operation of your business – can be challenging, especially when the message needs to be delivered to hundreds or even thousands of employees. This no-nonsense, 15-minute session delivers a straightforward message that discrimination and harassment based on factors such as race, religion, sex, disability, and age simply won’t be tolerated, and also spells out the potential consequences for violating these important policies.
  • 42 Request Info

    Enterprise Risk Management in the New World: Cyber Security, Business Continuity & Disaster Recovery - How they all fit together

    This session will give you an overview for ERM in Program Management and Project Management. You will receive valuable information that you can implement. This is a must in the new world that is facing new risks every year. Assessing risk, architecting, implementing, testing and monitoring solutions, while reducing their exposure to global threats, and protecting its employees and assets. Learn Risk Assessment, Impact Analysis, Strategic Planning, Plan Documentation, Testing and Exercises and Audit • Data Criticality Analysis (DCA) • Data Backup Plan (DBP) • Emergency Response Plan (ERP) • Business Continuity Plan (BCP) • Contingency Testing Plan (CTP) • Disaster Recovery Plan (DRP) • Crisis Management Plan (CMP) • Cyber Security Incident Response Plan (CSIRT)
  • 43 Request Info

    Requirements for Establishing an Effective Cleaning Validation Program

    GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
  • 44 Request Info

    Seminar on Why is FDA at my Facility, and what do I do During an Inspection

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.
  • 45 Request Info

    Seminar on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmet

    This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems.
  • 46 Request Info

    Seminar on Construction: OSHA Construction Hazards for any Jobsite

    Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past. Location: Los Angeles, CA Date: July 28th & 29th, 2016 and Time: 9:00 AM to 6:00 PM Venue: DoubleTree by Hilton Hotel Los Angeles Downtown Address: 120 South Los Angeles Street, Los Angeles, California, 90012, USA Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until June 20, Early Bird Price: $1,295.00 from June 21 to July 26, Regular Price: $1,495.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/OSHA-Construction-Hazards Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 47 Request Info

    Seminar on HIPAA for the Compliance Officer

    I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule Location: Chicago, IL Date: July 21st & 22nd, 2016 Time: 9:00 AM to 6:00 PM Venue: Four Points by Sheraton Chicago O'Hare Address: 10249 WIrving Park Road, Schiller Park, IL 60176, United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate – without stay) Until June 10, Early Bird Price: $1,295.00 from June 11 to July 19, Regular Price: $1,495.00 Price: $1,695.00 (Seminar Fee for One Delegate – with stay) Until June 10, Early Bird Price: $1,695.00 from June 11 to July 19, Regular Price: $1,895.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/HIPAA-for-the-Compliance-Officer
  • 48 Request Info

    Seminar on Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)

    The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
  • 49 Request Info

    GMP for Quality Control and Contract Laboratories 2017

    Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
  • 50 Request Info

    Medical Devices Compliance 2016 in USA

    Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device! The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease..." If the product’s intended us has some relationship to health, and the product is not a drug, it's possible to define it as Medical Device.
  • 51 Request Info

    Requirements for Supplier Management 2016 for Medical Device Manufacturers

    This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.
  • 52 Request Info

    Cleaning Validation Requirements 2016

    This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
  • 53 Request Info

    Best Practices for FDA Inspection 2016

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.
  • 54 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place.
  • 55 Request Info

    Risk Management in Medical Device Design 2016

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company. In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. We'll cover the history and requirements for design controls.
  • 56 Request Info

    Food transportation food safety rules: New FDA FSMA Rules

    Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, personnel training and certification, inspection and data collection, maintenance and reporting that provides evidence of compliance.
  • 57 Request Info

    Conference on Validation and Part 11 Compliance of Computer Systems and Data – GlobalCompliancePanel 2016

    Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are on target of inspectors. The large numbers of FDA warning letters also demonstrate that the industry struggles with either understanding or implementing the regulations. This 2-day interactive course provides the regulatory background and guides attendees through the complete equipment qualification and computer system validation processes from planning to reporting. It also helps to fully understand not only the text but also the meaning of Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. Location: Zurich, Switzerland
  • 58 Request Info

    Statistical Process Control & Process Capability – GlobalCompliancePanel 2016

    This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed to other useful charts for handling multiple sources of variation (within/between) and short production runs. Practical aspects of implementing SPC on the shop floor are also discussed. Estimating process capability for both normal and non-normal data is discussed. The meaning and limitations of popular capability are presented in detail. This highly interactive course will allow participants the opportunity to practice applying SPC techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively for their own processes. Venue: The DoubleTree Baltimore-BWI Airport Address: 890 Elkridge Landing Road - Linthicum, MD 21090
  • 59 Request Info

    FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices – GlobalCompliancePanel 2016

    This seminar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality. We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement. We'll discuss tools and metrics for understand the state of your QMS and how to identify and prioritize opportunities for improvement. We'll discuss the 4 major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections. Throughout the seminar, we'll emphasize the regulatory expectations and how you can translate them into your QMS. In each section, we'll cover lessons learned from recalls, 483s, and warning letters. We'll discuss myths and challenges and how you can avoid common problems. And will discuss best practices that you can easily adopt and will set you off on the right foot.
  • 60 Request Info

    Seminar on Preparing to Comply with the New FDA FSMA Rules – GlobalCompliancePanel 2016

    Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits. According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls. Venue: DoubleTree by Hilton Hotel San Francisco Airport Address: 835 Airport Blvd., Burlingame CA 94010-9949