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Courses

  • 1 Request Info

    Webinar on Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

    Understand how to have a structured approach to minor component identification and quantitation of low-level compounds for impurity and degradation. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Identification-and-Quantitation-of-Low-Level-Compounds-for-Impurity-and-Degradation-Analyses-502236/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar on Implementing the ASTM E2500 Validation Method

    This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach. Price:$150.00. 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-the-ASTM-E2500-Validation-Method-509460/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar on IQ, OQ, PQ in the Verification and Validation Process

    Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You'll also learn the essentials of validation planning, protocol writing, and change management. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/IQ-OQ-PQ-in-the-Verification-and-Validation-Process-503996/FEBRUARY-2019-ES-TRAININGREGISTRY
  • 4 Request Info

    Webinar on Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

    What are the strategies to be implemented before your laboratory undergoes a GMP inspection. Join the webinar to learn more. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Laboratory-Inspection-Readiness-Implementing-GMPs-for-the-Pharmaceutical-Laboratory-504036/JANUARY-2019-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar on How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

    Learn how to prepare for an FDA inspection and how to behave during one by attending this webinar by Dr. Loren Gelber. Register Today. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/How-to-Prepare-for-FDA-Inspections-and-Customer-Audits-of-Pharmaceuticals-504175/JANUARY-2019-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar on FDA Precedent: Procedural Steps to Issue a Mandatory Recall of Herbal Drug

    Join this instructive program, where speaker will set forth the facts that how can a food mandatory recall authority be used against a drug? Register Today. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/FDA-Precedent-Procedural-Steps-to-Issue-a-Mandatory-Recall-of-Herbal-Drug-502773/JANUARY-2019-ES-TRAININGREGISTRY
  • 7 Request Info

    Validation and 21 CFR Part 11 Compliance of Computer Systems

    This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.
  • 8 Request Info

    Seminar on Phase I GMPs

    This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
  • 9 Request Info

    Webinar On How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry

    Learn how to manage CRO-CMO-Vendor used in the Biopharma industry and how to ensure vendor oversight for FDA and EU regulated organizations. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/How-to-Demonstrate-Vendor-CRO-CMO-Oversight-in-the-Biopharma-and-Device-Industry-509016/JANUARY-2019-ES-TRAININGREGISTRY
  • 10 Request Info

    Implementing a Robust Data Integrity Program- 2019

    Overview: As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance. This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. Why should you Attend: Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe.
  • 11 Request Info

    Webinar on Tobacco Industry Trends for Computer Systems Regulated by FDA

    Get an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry. This course will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Tobacco-Industry-Trends-for-Computer-Systems-Regulated-by-FDA-508423/JANUARY-2019-ES-TRAININGREGISTRY
  • 12 Request Info

    How to be Efficient and Compliant with Part 11, Validation

    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.
  • 13 Request Info

    How to Determine the Appropriate Levels and Reporting Categories

    Overview: Change management system should be structured according to the firms Pharmaceutical Quality System (PQS) and should be based on ICH Q8, ICH Q9, and ICH Q10. The change management system should also be designed to cover all aspects of all products and processes utilized at the facility. Thus, any proposed change should undergo a clear and logical evaluation to assure that implemented an item do not affect the current state of control.
  • 14 Request Info

    Regulatory Requirements for Batch Record Review

    Overview: Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 15 Request Info

    Concise SOPs that your (Employees) can Easily Follow

    Overview: Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
  • 16 Request Info

    Webinar on EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials

    Attain an understanding of the General Data Protection Regulation (GDPR). Be able to understand the key of the main tenets of GDPR which impact on clinical trials. Consider data breaches. Understand the role of the Data Protection Officer (DPO). 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/EU-General-Data-Protection-Regulation-GDPR-Compliance-for-Drug-development-and-Clinical-Trials-504942/NOVEMBER-2018-ES-TRAININGREGISTRY
  • 17 Request Info

    Which are Compliant for Inspections for a [GXP Compliance]

    Overview: This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements. Why should you Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector's inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can't understand them, and too many times we've seen procedures being constantly revised.
  • 18 Request Info

    R2 Addendum- Changes Impacting Sponsors-CRO-Sites

    Overview: Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development. In 2016, the ICH revised the E6 guidelines to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.
  • 19 Request Info

    Webinar on Human Error Prevention in Pharmaceutical Manufacturing

    This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. 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/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar on Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

    Understand the validation and regulatory requirements for the sterile filtration of pharmaceutical products. 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/Sterile-Filtration-of-Pharmaceutical-Products-Validation-and-Regulatory-Requirements-502453/AUGUST-2018-ES-TRAININGREGISTRY