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  • 1 Request Info

    NIST Cybersecurity Framework For Computer Systems Validation

    Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House.Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?
  • 2 Request Info

    Webinar On OSHA's Hazard Materials Management & Chemical Safety

    This course will describe how to evaluate chemical hazards and develop controls to protect workers and the public from the hazard. Additionally, the webinar will discuss the need for OSHA training and present techniques for developing a safety plan that addresses the use of chemicals.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/OSHAs-HAZARD-MATERIALS-MANAGEMENT-CHEMICAL-SAFETY-504927/AUGUST-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On GMP Auditing of Facilities Performing Cell-Based Methods

    Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/GMP-AUDITING-CELL-BASED-METHODS-506592/AUGUST-2017-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar On Implementing Effective Safety Audits

    Nobody at your facility has been hurt in more than a year. Weekly inspection forms are returned with no non-compliances. Are the facility's safety plans really working that well or is it just luck? Conducting a safety audit is one of the proven ways to answer that question.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/IMPLEMENTING-EFFECTIVE-SAFETY-AUDITS-507553/AUGUST-2017-ES-TRAININGREGISTRY
  • 5 Request Info

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 6 Request Info

    Validation, Verification and Transfer of Analytical Methods from FDA/EMA, USP and ICH 2017

    Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated. Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
  • 7 Request Info

    HIPAA - Understanding Compliance Program Requirements 2017

    Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive two-day training course.
  • 8 Request Info

    Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

    Japan's classification system differs from that of the United States or European Union Medical devices are classified to Class I, II, III, or IV depending on their risk level Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements Strict new package insert requirements Change to MAH Licensing rules A new MAH License category for In Vitro Diagnostic (IVD) devices A new registration system for manufacturers A new QMS conformity assessment system New formats for pre-market certification and pre-market approval applications Expanded scope of third party certifications Rules for software as a medical device Rules for transferring pre-market certifications And Much More...
  • 9 Request Info

    Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes 2017

    Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.
  • 10 Request Info

    Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

    Japan's classification system differs from that of the United States or European Union Medical devices are classified to Class I, II, III, or IV depending on their risk level Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements Strict new package insert requirements Change to MAH Licensing rules A new MAH License category for In Vitro Diagnostic (IVD) devices A new registration system for manufacturers A new QMS conformity assessment system
  • 11 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements
  • 12 Request Info

    Validation, Verification and Transfer of Analytical Methods 2017

    Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
  • 13 Request Info

    FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

    The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.
  • 14 Request Info

    What to Expect in a Federal HIPAA Audit & How to Avoid Audit 2017

    I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.
  • 15 Request Info

    Webinar On USP General Chapter 800 Hazardous Drugs-Handling in Healthcare Settings

    This course will cover the current regulations and importance of preparing and handling sterile and hazardous pharmaceuticals. It will also review the proposed regulation concerning all aspects of handling hazardous drugs and is appropriate for medical, nursing and pharmacy workers. Understanding these regulations will allow users to future-proof their facility and employ best work practices when performing both non-sterile and sterile HD handling.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/USP-HAZARDOUS-DRUGS-HANDLING-HEALTHCARE-505360/AUGUST-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On Risk Management in Clinical Trials: What will inspectors look for?

    Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP guideline, recently released EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/RISK-MANAGEMENT-CLINICAL-TRIALS-506955/AUGUST-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On C-TPAT Annual Security Training

    The Customs Trade Partnership Against Terrorism is one of the most important trade partnership programs offered to the US trade community in the last 15 years. Benefits associated with membership include expedited customs clearance and mitigation to possible CBP fines and penalties for acts of common compliance error which is now greatly enforced since the passage of the Trade Facilitation and Trade Enforcement Act of 2016.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link
  • 18 Request Info

    Webinar On Explain the Laws & Regulations Governing EMS in Healthcare Profession

    Learn to identify, understand, and apply laws and regulations governing emergency medical services in the health care profession with an in-depth analysis of a state agency's regulation of these life-or-death medical services. This webinar conducts a detailed review of how one state structures the regulation of emergency medical services. A special concluding segment covers how this regulation affects everyday legal cases in the law.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/REGULATION-EMERGENCY-MEDICAL-SERVICES-506810/AUGUST-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Current Topics on Management of GMP Data Integrity

    Over 40 warning letters cited data integrity issues in 2016, and the trend has continued in 2017. This webinar gives an overview of the current regulatory climate regarding data integrity, including regulators' expectations for ensuring that the data lifecycle is integral. Highlights from the recent publications by FDA, MHRA, IPSE, and WHO will be discussed, as well as strategies for prevention, detection, and remediation of issues will be explained.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/GMP-DATA-INTEGRITY-509710/AUGUST-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On Lyophilization: What you need to Know, Validation and Regulatory Approaches

    More and more of today's (and tomorrow's) drugs are biotech drugs, complex and often highly sensitive molecules. External factors such as oxygen, sunlight, and pH values can negatively affect biotech products, leaving marketers looking for innovative ways to protect and preserve these important compounds until they can be administered to patients. The lyophilization process can protect biological activity, extend shelf life, and even increase dosing precision. In recent years, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilized drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilizationPrice:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/LYOPHILIZATION-PROCESS-FDA-REGULATORY-508301/AUGUST-2017-ES-TRAININGREGISTRY