Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated. It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the…

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…

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 interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control, arguments for the micro lab being the spearhead of contamination investigations, step-by-step instructions for investigating and resolving microbial excursions in water and associated systems, and how to rationally validate the operation and microbial control in a water systems in a manner that will please FDA. In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, root cause investigation and response to microbial excursions, or regulatory…

In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance with the New 21 CFR Part 11 regulations and how to use risk management for improving system performance and process improvement. Why Should You Attend: This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore…

This GMP webinar will help you understand the compliance requirements concerning Annex 13 of the GMP guide. The session will review the guideline to cover the key areas of compliance including: The role of the "Qualified Person", Packaging, labeling, reconciliations that should take place for each product and each production stage, and Comparator product requirements etc. Areas Covered in the Seminar: Review the role of the "Qualified Person" who must have access to the Product Specification File as the basis for assessment of the suitability for release and certification of a particular batch. Packaging instructions requires expressly with a view…

This FDA cGMP training webinar will discuss US FDA’s approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate. This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. Areas…

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…

Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are needed to support these specifications. This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but…

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…

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 addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations. This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems. Areas Covered in the Seminar: What should be investigated - Complaints, audit observations, deviations,…

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 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.

This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations. Areas Covered in the Seminar: Current Regulatory requirements for testing particulates in protein Therapeutics. The limitations of the USP methods for testing Particulates. What are the methods available for analysis of subvisible particles in protein therapeutics? Comparison of size ranges, sensitivity limits and capabilities of the various methods. Equipment available for performing these tests. Advantages and disadvantages of the methods. Who Will Benefit: This course will benefit all individuals involved in Formulating or Testing Protein Therapeutics QC Supervisors and…

This bi-annual conference brings together scholars and experts from around the world to share water-related research and is held concurrently with the awards ceremony for the Prince Sultan Bin Abdulaziz International Prize for Water. Conference Objectives: *To provide a scientific framework for awarding the Prince Sultan Bin Abdulaziz International Prize for Water, and for announcing the topics of research for the 5th award. *To exchange knowledge and share information in water resources and desert-related fields. *To explore the use of new technologies in the study of arid and semi-arid environments and their natural resources. *To provide an opportunity for decision…

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…

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 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 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