This sterilizing grade filter validation training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes. Areas Covered in the Seminar: What is filter qualification, what is filter validation. Regulatory requiremnents validating sterilzing grade filters. Various validation requirements and processes. Practical experiences with filter validation. Documents required. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need to validate their sterilizing grade liquid filters within the pharmaceutical and biotech processes. The employees who will benefit include: End-users of sterilizing grade filters Validation manager or specialists Regulatory manager or support…

This China life science compliance based webinar will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations. This 3 hrs course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. Who Will…

This Data Monitoring Committees (DMC) webinar will guide you through the essential elements of data monitoring committees and how to set up for it successfully. Areas Covered in the Seminar: The historical background of why Data and Safety monitoring is essential. The purpose of the Data and Safety monitoring plan. The Regulatory requirements for safety monitoring. Studies requiring a formal Safety Monitoring Committees. What does the "Charter" of a DMC compose of? What is the composition and function of a DMC? What types of studies "require" a DMC? Conflict of interest and the DMC. Who Will Benefit: This Webinar will…

In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why Should You Attend: Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites),…

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. Why Should You Attend: This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFs course will take participants through a step-by-step process of DMF preparation and explain the types…

In this 505(b)(2) related webinar, know the complete details, key strategies, regulatory considerations, and marketing strategies for developing 505(b)(2) products. Areas Covered in the Seminar: The 505(B)(2) regulation and guidance from the FDA. Strategic considerations before embarking on a 505(b)(2) development project. Intellectual property issues with such products. Key development steps for such products. FDA’s review process and ongoing consultation. Challenges to developing 505(b)(2) product and possible solutions. Examples of successful strategies for developing such products. Searching for a 505(b)(2) project, future trends. 505(b)(2) and biosimilars.

Continuing in its Health Outcomes series, marcus evans invites you attend the 2nd Annual Health Outcomes and Pharmacoeconomics Research Conference. Hear from industry leaders within Bio/Pharmaceutical and Medical Device companies on establishing health economic value propositions to maximize your comparative effectiveness strategies. Attending This Conference Will Enable You To: · Review global health economic and outcomes research strategies · Understand comparative effectiveness research trends and regulation · Establish patient reported outcomes and access to data · Create market access, reimbursement and talent management strategies marcus evans invites senior level executives from leading biopharmaceutical and biotech companies in: -Health Outcomes Research…

marcus evans invites you to attend the Social Media for Pharma Conference specific to the needs to of those within the Pharmaceutical, Medical Device and Healthcare Industries. Hear from industry experts as they assess the importance of a distinct social media plan in preparation for FDA guidance in the pharmaceutical industry. Attending this conference will enable you to: 1. Explore the current social media outlets and trends 2. Understand the pending FDA regulatory guidance for social media and how it impacts strategy and compliance 3. Integrate an effective social networking strategy into your organization from a business and compliance perspective…

This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures. Areas Covered in the Seminar: Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins) Drug Development Process cGMP requirements for analytical test methods Review ICH Q2 A&B guidelines for method development/validation Module II Development and Validation Stability Indicating Methods ( 35 mins) Design method specificity through forced degradation activities Discuss validation characteristics Module III. Designing Method Validation Protocols ( 35 mins) Establish Method Validation Protocol Establish Method Validation Protocol Module…

This pharma training will discuss how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and learn how to measure the thresholds to report for regulatory submission. Learning Objectives: Upon completion of this session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recoding impurities in pharmaceutical labs. Areas Covered in the Seminar: Understand regulatory expectations. Discuss warning letters and citations. Understand regulatory requirement guidelines surrounding impurities in…

This drug safety training will discuss the various factors to be considered and the principles of risk assessment to be followed during drug development to minimize risk. Areas Covered in the Seminar: Risk conceptualization. Goals of project risk management. Risk management planning & safety review teams. Intellectual property. Pharmacovigilance planning in product risk management. Unexpected study results: efficacy, dosage, adverse events & toxicology. Data analysis, interpretation and presentation. Essentials of Data Monitoring Committees. Drug disposal and environmental impact. Labeling as a hallmark of risk management efforts. Post-marketing risk. Who Will Benefit: The Webinar will present valuable risk management information and…

This microbial excursions training will address microbial excursion and the best practices for troubleshooting them. Attendees will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences and details of specific excursion. Areas Covered in the Seminar: Review data from “real-world” examples. Learn how to develop solutions to your microbial control problems. Learn both the preventative measures and corrective actions. What are the best Practices in contamination prevention. Recent outbreaks of fungal excursions will be discussed and studied. Guidance to identify and rectify Cleaning and Disinfection, Personnel Practices, and Facility Design Flaws.…

This Webinar will discuss the modalities of proper investigations for environmental excursions and how to find the root cause and take appropriate preventive actions. Areas Covered in the Seminar: Why investigate environmental excursions. Identifying an excursion - now what do I do? Compling all necessary information. Analzying information (including trend analysis). Driving to root cause. Defining appropriate corrective actions. Evaluating effectiveness of corrective actions. Who Will Benefit: This webinar will provide valuable assistance to regulated manufacturing and laboratories that support microbial testing. Microbiologists Quality Control personnel Environmental Monitoring personnel Quality Assurance

In this excel Spreadsheet validation full day webinar training, learn the best way to design and validate the excel spreadsheets. Learn what the requirements are of excel validation and how to implement it to comply with regulations. Why Should You Attend: Excel spreadsheets used in regulated environments should be validated and comply with other FDA requirements. In this interactive one-day on-line seminar Dr. Ludwig Huber will give an introduction to FDA, GAMP® 5 and other requirements for validation of excel sheet and present approaches for implementation. This is a comprehensive course covering validation, design, testing of functions along with how…

This Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures. Areas Covered in the Seminar: * Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity. * Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them. * Benefits and drawbacks for using each type of disinfectant used in the Pharmaceutical Industry. * Bodies that regulate disinfectant manufacturers and testing required by manufacturer’s for label claim. * Learn disinfectant testing…

This contamination control webinar will discuss how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical and how it can be addressed in developing a successful contamination control program. Areas Covered in the Seminar: * Developing effective ways to address spore excursions. * Troubleshooting real world experiences. * Developing preventative action plans. * Learn ways to improve facility design and maintenance. * The most effective sporicidal chemistries will be discussed in detail. * Cleaning and Disinfection Methods will be addressed. * Warning Letters and 483’s from FDA will be discussed and addressed. Who Will Benefit:…

This FDA compliance webinar will evaluate the FDA expectations in the near term and further out in the future and how it will boil down to new regulatory climate. Areas Covered in the Seminar: * Stated expectations and the one-year result. Targets. * Avoid complacency from past "good" FDA actions. * Avoid complacency from just completed "good" ISO feedback. * FDA's desired responses from industry. * How to respond now -- where to shift focus first. * Where to direct scarce resources. * Anticipated future directions. * Maintain 'the edge'. Who Will Benefit: This webinar will provide valuable assistance to…

This 21 CFR part11 virtual conference will discuss the scope and how to pass a part 11 inspection and how to best use and implement audit trails for part 11 compliance. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing…

The objective of this Conference is to bring together researchers from both academia and industry under one roof, to discuss and to share the latest developments in the field of nanotechnology MAJOR TOPICS Nanomaterials including Nanoparticles, Nanocrystals , Nano-porous materials, 2 Nanomechanics, Nanotribology, Nanocomposites, Nanoelectronics, Nano-Magnetics, & Quantum Computing, Nanobiotechnology , Nanomedicine, Nanotubes/Nanowires/Quantum Dots, NEMs, MEMs, Nano-Fluidics, Nano-Actuators, Nano-Sensors, Nano-robotics, 7 Nano-Fabrication, Nano-Lithography, Nanotechnology for Energy (fuel cell, solar cell, hydrogen storage), Other related topics CALL FOR PAPERS The organizing committee invites original research papers for Oral/Poster presentation. Authors are requested to submit an abstract of their work in about…

This clinical trial audit training reviews the key elements of quality auditing processes and correlates them to the ICH guidelines and applicable FDA regulations. This Quality auditing in clinical trial training will include the key elements of quality auditing process, auditing methodology, and reporting techniques. In addition, this session will focus on reviewing recent FDA inspection findings and areas of common deficiencies. It will help you understand how key elements of quality auditing process correlates to ICH guideline and other applicable regulations. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Medical Devices, and…