UPCOMING WEBINARS

  • 3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit

    6,999.0013,995.00

    FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

    This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

    Why You Should Attend:

    FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

    This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

    This session will provide some insight into current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit of computer systems that are regulated.There are some key areas of focus that will be covered that will help you to plan for an on-site inspection.

    Areas Covered in the Session :

    • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
    • GxP – Good Manufacturing, Laboratory and Clinical Practices
    • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
    • Data Archival to ensure security, integrity and compliance
    • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
    • Recent FDA findings for companies in regulated industries
    • The resources, documentation and room preparation necessary to adequately prepare for inspection
    • Interactive Q&A Session

    Who Should Attend:

    • Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity, and computer system validation (CSV)
    • Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment
  • Building QbD and RBQM Systems into Clinical Operations

    3,000.007,000.00

    This session is focused on Quality by Design (QbD) and new regulatory requirements for Risk-Based monitoring and building Risk-Based Quality Management (RBQM) systems.

    Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention on a world-wide basis. As the industry’s utilization of risk-based monitoring continues to increase along with the development and expansion of the area of RBQM, the need for the integration of these two concepts becomes apparent.

    The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site, CROs and Sponsors level.

    Why You Should Attend:
    RBQM is the proactive identification and mitigation of risks. By combining these two concepts, the inherent risks identified up front can feed into the design of the risk-based monitoring plan QbD. RBQM requires development of well-defined and relevant metrics, key performance and quality indicators (KP-QI), as well as a solid process for review and follow-up of the identified signals. Both aspects need to be supported by robust information management as well as training and cross-functional communication strategies.

    Practical aspects of developing key performance and quality indicators at all stages of clinical trials will be discussed. Building Quality Management Systems for Sites and Sponsors: Cause-Effect Analysis and Corrective Action Preventive Action (CAPA) plans will be also available as a workshop as part of this course providing an interactive exploration of quality management systems and preparing you to build them in both site and sponsor settings to improve clinical trial operations efficiency and accuracy.

    Areas Covered in the Session :

    • Describe principles of Quality by Design (QbD) and new regulatory requirement for Risk-based monitoring
    • Develop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems
    • Identify and manage risks of clinical trials
    • Perform Cause-Effect Analysis for identified risks and develop mitigation strategy
    • Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
    • Develop effective Corrective Action Preventive Action (CAPA) Plans

    Who Should Attend:

    • Clinical Quality Assurance Auditors
    • Clinical Quality and Compliance Professionals
    • Clinical Research Associates
    • Project Managers
    • Medical Monitors
    • Regulatory Affairs Professionals
    • Clinical Research Coordinators
    • Clinical Principal Investigators
    • IRB Administrators and Members
  • Data Quality Culture and Building a Corporate Data Integrity Plan

    3,000.007,000.00

    The purpose of the webinar is to bring attendees attention to behaviors and conducts that companies should consider when considering the implementation of a corporate data integrity plan.

    Areas Covered in the Session :
    Quality Culture to Assure Data Integrity:

    • Falsification vs Bad Practice
    • Cressey’s ‘Fraud Triangle’
    • Managing Behavior
    • Possible Governance Models for Data Integrity

    Corporate Data Integrity Plan:

    • Risk-Based Plans and Organizational Structures
    • Quality Management System enhancements
    • Data Life Cycle & GXP Data Governance
    • Metrics and Reporting to SLT

    Who Should Attend:

    • Quality Assurance Departments
    • Quality Control Departments
    • Research and Development Departments
    • Regulatory Affairs Departments
    • Manufacturing Departments
    • Production Departments
    • Documentation Departments
    • Site Directors
  • Establishing and Regaining Control of Cleanroom

    3,000.007,000.00

    This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.

    Upon completing this course participants should:

    • The critical steps needed to release the room for manufacturing will be discussed.
    • Routine cleaning and disinfection strategies will be covered as well as the latest in equipment and application.
    • Establishing control of the clean room after a worst case event.
    • Excursion events will be discussed and case studies will be covered regarding excursion events.

    Areas Covered in the Session :

    • Critical steps in starting a new clean room operation
    • Critical Steps need to release the clean room for manufacturing
    • Routine cleaning and disinfection strategies
    • Utilities
    • Contamination
    • Environmental monitoring
    • Establishing control of the clean room after a worst case event
    • Excursion events
    • Case studies regarding excursion events
    • Excursion investigations and troubleshooting parameters

    Who Should Attend:

    • QA and QC managers
    • Disinfectant validation managers
    • Operations managers
    • Clean room managers
    • Personnel and contractors that clean and disinfect clean rooms
    • EH&S managers
    • Regulatory compliance managers and environmental monitoring managers
  • Failure Investigation And Root Cause Analysis (RCA) Seminar

    25,960.00

    This is the advanced and skill based training in specific subjects related to failures investigation and root cause analysis (RCA) –effective investigations to identify the actual, factual root cause and how to develop effective CAPA strategy to eliminate forever in good manufacturing processes and quality systems. This course details with current regulatory expectations on failures investigation and root cause analysis (RCA) with implementation of effective CAPA.

  • FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

    3,000.007,000.00

    The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2.

    The 505(b)2 regulatory pathway allows an applicant to submit a new drug application for approval of different formulations, dosage forms, indications or combination products of drugs and biologics that have been already approved by the FDA.

    Basically, 505(b)2 permits an applicant to rely on the safety and effectiveness data of a previously-approved product.

    More specifically, an application under the 505(b)2 is one for which one or more of the investigations relied upon by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted according to the applicable law.

    For biologics, the 505(b)2 pathway offers a narrow category of biologics for marketing approval. It should be noted for biologics that any product approved under the 505(b)(2) pathway will be considered approved under the 351(k) pathway once the ten-year phase-in period is complete according to the Affordable Care Act (ACA).

    This webinar is intended to help industry better understand FDA’s regulatory pathway 505(b)2 so that the 505(b)2 pathway can be better used for FDA approval of certain drugs or biologics.

    The speaker will walk you through the FDA’s current recommended practices.

    Areas Covered in the Session :

    • Applicable Statute(s) and Regulations
    • Definitions
    • Common Misconception
    • Categories Approvable under 505(b)2
    • 505(b)2 Requirements
    • 505(b)2 Applications: Contents
    • CMC Requirements under 505(b)2
    • Drug Examples Approved under 505(b)2
    • Injectable Biologics Approved under 505(b)2
    • Important Considerations
    • PASS-IT Recommendations: Best Practices

    Who Should Attend:

    • CEOs
    • VPs
    • Compliance Officers
    • Attorneys
    • Regulatory Affairs
    • Clinical Affairs
    • Quality Assurance
    • R&D
    • Consultants
    • Contractors/Subcontractors
    • Anyone Interested in the FDA Drug Review and Approval Processes
  • FDA Rules for Pharmaceutical Analytical Method Validation

    5,000.00

    FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.

    Why You Should Attend:

    All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended..

    Areas Covered in the Session :

    • General Information
    • Specificity
    • Accuracy
    • Precision
    • Sensitivity
    • Linearity
    • Range
    • Robustness
    • Reproducibility

    Who Should Attend:

    • Analytical Method Development Supervisors
    • Analytical Method Validation Supervisors
    • Method Research Chemist
    • Analytical Chemists
    • QC and R&D Laboratory Supervisors
    • Regulatory Affairs Supervisors
  • Pragmatic and Effective Vendor Qualification Program for cGMP Compliance

    3,000.007,000.00

    Regulatory agencies such as US FDA and others expect pharmaceutical companies to treat their suppliers and contractors as an extension of their own operation. Hence oversight of their vendors’ quality compliance is of paramount importance.

    A robust, but pragmatic and effective vendor qualification program must be established by the manufacturer of drugs, biologics, medical device, & combination products. This will also apply to the vendors and contractors who have the responsibilities of oversight over their own suppliers and contractors.

    Supply chain is becoming increasingly complex due to changing business & regulatory environment in the recent time. Importance of robust due diligence via effective audits of the supply chain is being emphasized by the regulatory agencies around world. Hence, setting up on effective and pragmatic vendor qualification program has become a big challenge to the industry.

    Attendees will learn how they can establish such a robust, risk based vendor qualification program in a cost effective manner, but in compliance with the applicable regulatory requirements.

    Areas Covered in the Session :

    • Changing current business and regulatory environment
    • Complexity of supply chain & Strategies for compliance
    • Regulatory & quality compliance challenges
    • Importance of vendor selection process & potential business & regulatory consequences
    • Elements of vendor qualification program
    • How to set up a robust, pragmatic & cost effective vendor qualification program for regulatory compliance. Win-Win Strategy & Partnership with vendors
    • “Seeing is believing” & setting up a suitable, cost effective audit program for compliance
    • Performance monitoring & effective communication
    • Application of risk management principles & life cycle approach to vendor qualification program

    Who Should Attend:

    • QA and QC managers
    • Quality Assurance Departments
    • Quality Control Departments
    • Supply Chain Departments
    • Compliance Departments
    • Research and Development Departments
    • Regulatory Affairs Departments
    • Manufacturing Departments
    • Engineering Departments
    • Operations Departments
    • Production Departments
    • Sales and Distribution Departments
    • Marketing Departments
    • Documentation Departments
    • Project Managers
  • SOP’s for Bioanalytical Methods Validation

    3,000.007,000.00

    Bioanalytical assays are used in a variety of laboratory contexts, from clinical laboratories, to research and development, to quality control and manufacturing. These laboratory assays have become crucial to the regular operations of all sorts of laboratories. However, each assay has particular pitfalls that makes transitioning from one assay to another difficult. Each type of bioanalytical assay has its own particular challenges and opportunities, and understanding where the opportunities are is key to making sure validations are successfully completed.

    This assay will cover the three broad classes of bioanalytical assays: immunoassays, molecular assays and mass spectrophotometry based assays. We will look at the particular advantages and challenges in each class, how to operate within ease class and the key challenges in moving between classes. This will ensure that assay validation goes off without a hitch, and new assays can be deployed in a timely manner.

    Areas Covered in the Session :

    • Defining what a bioanalytical method is
    • Necessary steps to validate an immunoassay
    • The challenges and opportunities of validating a molecular assay
    • Needs for mass spectrophotometry assays
    • Issues in transitioning between assay classes
    • Best practices for all bioanalytical methods

    Who Should Attend:

    • Research and Development Departments
    • Quality Control Departments
    • Assay Development Departments
    • Assay Validation Departments
    • Documentation Departments
    • Clinical Diagnostics
  • Sterilization of Pharmaceutical Products and Medical Devices

    3,000.007,000.00

    This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

    Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristics of your product will determine what method will be used. This webinar will go over the four methods of sterilization and why one method would be chosen over the other.

    Areas Covered in the Session :

    • Regulations relating to sterilization of products
    • Methods of sterilization
    • Why one method is used over another
    • Validations of the sterilizations method
    • Parametric release

    Who Should Attend:

    • Quality Assurance Departments
    • Quality Control Departments
    • Manufacturing Departments
    • Regulatory Departments
    • Compliance Departments
    • Quality system auditors
    • Microbiology analysts and technicians
    • Consultants
  • Toxic Impurities in Active Pharmaceutical Ingredients

    3,000.007,000.00

    The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients (APIs). Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the presence of the carcinogens N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) orN-nitroso-N-methyl 4-amino butyric acid (NMBA). These carcinogens were found to be present above the low interim specifications recently established by FDA.

    The analytical method used to find these substances will be discussed. The public information about how they got into these drug products, and its implications for the future, will be considered. European Medicines Agency position on nitrosamines will also be presented. This training will provide valuable information to those who plan and conduct cleaning validations and analyses of APIs, as well as pharma company management.

    Learning Objectives:

    • What are toxic impurities
    • What is trace analysis
    • What are nitrosoamines
    • How are nitrosamines formed
    • How did they get in sartans
    • What might this mean for other toxic impurities

    Areas Covered in the Session :

    • General Information about the limits for toxic impurities
    • Handling trace analysis
    • Structure and properties of NDMA
    • Structure and properties of NDEA
    • Structure and properties of NMBA
    • How are nitrosamines formed?
    • How did it get in sartans?
    • Some thoughts on other potential toxic impurities

    Who Should Attend:

    • Quality Departments
    • Research and Development Departments
    • Regulatory Affairs Departments
    • Validation Departments
    • Everyone involved with Analytical Method Development and Validation
    • Everyone involved with New Product Selection
  • Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

    3,000.007,000.00

    Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

    This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file.

    Why You Should Attend:

    All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended.

    Areas Covered in the Session :

    • Trial Master File (TMF) background and rationale
    • Learn what content is required for a TMF for a clinical trial
    • The essential documents to include in a TMF
    • Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
    • Organizing and maintaining a TMF
    • How to provide quality assurance for the data included
    • Standard Operating Procedure required to support TMF
    • Developing a consistent system for locating TMF documents
    • Regulatory Inspection of TMF records and Preparation
    • Industry Standards and Best Practices
    • Interactive Q&A Session

    Who Should Attend:

    • Lead CRAs
    • CRA Managers
    • Project and/or Study Managers
    • Project and/or Clinical Trial Assistants
    • Clinical Operations Administrators
    • Quality Assurance Personnel
    • Compliance Teams
    • Validation Teams
    • Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
    • Consultants
    • Teams involved with CSV
    • Auditors engaged in the internal inspection of clinical trial documentation and practices
    Topic Background:
    The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.The Code of Federal Regulations states in 21 CFR 312.50:

    “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.”

    The European Directive 2005/28/EC states:
    “…trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.”

    ICH GCP, Section 8.1 describes “essential documents” as those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.

    A consolidated guidance for industry on Good Clinical Practice (GCP) in 1996 was published by the International Conference on Harmonization (ICH). The objective was to provide a unified standard for the United States, European Union, and Japan to facilitate mutual acceptance of clinical data by the regulatory authorities in these global jurisdictions.

    The ICH document provided guidance for companies in all ICH regions to establish trial master files that contain key documents that enable the evaluation of the conduct of a trial and the quality of data produced uniformly by all jurisdictions involved. In the US, there is no specific requirement from FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.