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Select your Industry/Regulation based training    Select FDA Compliance Medical Devices Pharmaceutical Clinical Compliance Biotechnology General Manufacturing Compliance Training Webinar Overview of Quality by Design View Details This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products. Price : $149.00   Instructor John Avellanet Recorded Webinar Quality Planning Process and Procedure View Details This Quality Planning training/webinar will define the Quality policy and plan with the help of procedure, Manual and templates where manufacturer decides how to apply these regulatory guidelines in developing a plan that consistently delivers high quality products and services. Price : $249.00   Instructor Ron Schoengold Recorded Webinar FDA?s Current Thinking for Industry cGMPs for Phase 1 INDs View Details This US FDA draft guidance documentation webinar/ training will give an insider?s insight into the new guidance and regulation and discuss the rationale for such. Price : $299.00   Instructor Sandra N. Whetstone Recorded Webinar Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP View Details This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Price : $299.00   Instructor Steven S Kuwahara Recorded Webinar Quality Expectations for Drugs and Biologics during Early Development: Phase 2 View Details This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development. Price : $299.00   Instructor Steven S Kuwahara Recorded Webinar Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA View Details This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. Price : $299.00   Instructor Steven S Kuwahara Recorded Webinar Technology Transfer of a Pharmaceutical Manufacturing Process View Details This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process. Price : $299.00   Instructor Rodney E Thompson Recorded Webinar Experiences of managing a quality management system for a virtual pharmaceutical company View Details This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities. Price : $249.00   Instructor Simon Forster Recorded Webinar Outsourcing analytical and pharmaceutical development View Details This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business. Price : $249.00   Instructor Michael Gamlen Recorded Webinar Viral Safety of Biopharmaceuticals from Process Development to Licensure View Details This Viral Safety webinar will provide case study examples that demonstrate the importance of pre-validation viral clearance data for optimizing a process step to provide robust viral clearance. Price : $149.00   Instructor Kathryn Martin Remington Recorded Webinar Tort Law and Strict Liability for FDA Regulated products-What every Regulatory Affairs and Quality Professionals should know View Details In this Training, essential elements of tort law, product liability and defensive strategies to protect your company will be outlined in detail. Price : $249.00   Instructor Robert J Michalik Recorded Webinar Pharmacovigilance aspects of licensing agreements View Details Regulatory expectations for reporting in multi-company development and marketing programs. Price : $249.00   Instructor Dr.Sidney Kahn Recorded Webinar Clinical Research Organization Audit for Good Clinical Practice View Details 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. Price : $299.00   Instructor Ron Schoengold Recorded Webinar Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics View Details This Product Safety training will guide you on how metrics can be used to analyze and improve the process for product safety. Price : $249.00   Instructor Dr. Carla Hagelberg Recorded Webinar Update of Pharmaceutical law in the EU -Focus on Generic Opportunities & Biosimilars View Details Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry. Price : $249.00   Instructor Elizabethann Wright Recorded Webinar Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect View Details This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. Price : $249.00   Instructor Peter Calcott Recorded Webinar GMP Expectations for Products Used in Early Phase IND Studies View Details This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. Price : $249.00   Instructor Steven S Kuwahara Recorded Webinar Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a Successful Transfer View Details This webinar will provide guidance in developing assays that will meet specifications thus reducing OOS and OOT results. Price : $249.00   Instructor Dr. Wise Blackman Recorded Webinar NEW Guidance for Industry: CGMP for Phase I Investigational Drugs View Details This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND). Price : $149.00   Instructor Jamie Jamshidi Recorded Webinar  Find Online Training

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