This FDA Compliance training will discussion on major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity. Areas Covered in the Seminar: . Pressures on FDA. . FDA Re-organization. . FDA changes in focus. . New Enforcement Resources. . What industry should expect of FDA. . FDA expectations for responses to FDA-483 observations. . FDA expectations for responses to Warning Letters. Note: Use this Promo Code(102040) to avail Discount of 10% on LIVE Purchase. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701699?channel=worldconf

ICRA topics are still developing. We encourage those who may be interested in the ICRA to save the date. Those who wish to submit potential ICRA topics should email Terry Rakestraw at aqua@vt.edu

Discussion on processes and effects of immunogenicity, screening methodologies to measure immune response, how to apply regulatory mandates and what are commercial repercussions of unwanted immune responses. Areas Covered in the Seminar: - Overview on the processes and effects of immunogenicity. - Impact on efficacy and safety. - Screening and confirmatory methods to measure immune responses. - Regulatory guidelines on immunogenicity of biologics; FDA, ICH, CHMP, EMEA. - Risk management strategy. For More Details: http://bit.ly/92mmFl

This laboratory documentation training Webinar will discuss the GMP requirements on laboratory records and how to streamline documentation system. Areas Covered in the Seminar: - Review cGMP requirements on laboratory records. - Define raw data. - Key factors of an effective documentation system. - Anatomy of an SOP. - Consequences of poor data records. - Discuss warning letters effecting the analytical data. Who Will Benefit: - Pharmaceutical scientists - Manufacturers or raw material and ingredients - Analysts and lab managers - QA managers and personnel - Regulatory affairs

In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance 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.This course explores proven techniques that reduce validation project time, often to one-third.Learn efficient documentation strategies for computer system validation and how to increase overall system…

This FDA Regulated Industries training/webinar will show you best method available today to make step-change improvements quality performance. Your will learn how to harness the ideas and energy of your employees for quality improvement. Areas Covered in the Seminar: - How to use measurements to drive behavior change - Why even the strictest of procedures and extreme supervisory oversight cannot achieve the level of quality performance you need to remain competitive - How to motivate your employees to follow up on their own initiatives to implement positive change in the workplace - How to guide your employees to maximize their…

This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined. Areas Covered in the Seminar: - Introduction. - Guidance documents QS regulation. - Major FDA 483 points. - Trends in FDA. - Determining best practice for the supplier audit. - Conducting a thorough audits. - FDA import detention prevention. - Questions to ask during the supplier audit. - Questions & Answers. For More Details:…

This drug development process training Webinar will give an overview of drug development process, the regulatory requirements and the analytical technology used for pharmaceutical analysis supporting R & D. Areas Covered in the Seminar : . Current Drug Development Process. . Regulatory Submissions in Pharmaceutical Industry. . Regulatory Requirements for pharmaceutical laboratories. . Factors affecting Quality of Medicines. . Discuss warning letters effecting the analytical labs. . Roles of the analytical Program. . Different types of Analytical Methods used to support Drug Development. Note: Use this Promo Code(102742) to avail Discount of 10% on LIVE Purchase. For More Details: http://bit.ly/dg1qha

This Viral Safety webinar training will discuss the testing used to generate data for risk assessment and train how to calculate viral risk. Learning objectives : How do I know if the viral clearance my process provides is enough? Retrovirus or Retroviral like particles are present in my production cell line. How does this impact my downstream process? How do I calculate viral risk? Areas Covered in the seminar: - The viral testing required for source materials. - Determine if there is enough viral clearance for your process . - How the testing for adventitious viruses is related to viral…

In this Pediatric Trials training learn how to evaluate the current issues and best practices in pediatric drug development, clinical investigation of medicinal products and non clinical evaluation of pediatric drug products. Areas Covered in the Seminar: - Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children. - Recent guidances on compliance and general considerations in the conduct of research on children. - General Considerations for the Clinical Evaluation of Drugs in Infants and Children. - Discuss Clinical Investigation of Medicinal Products in the Pediatric Population. - Nonclinical Evaluation of…

This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances. Areas Covered in the Seminar: - The goal of Forced Deg studies . - Stress conditions for Forced deg studies. - Degradants generated by these stress conditions. - Methods required to study these degradant. - Leveraging forced deg results to design stability studies. - Using forced deg results in specification setting. - Common pitfalls in Biologics Stability Studies. - Types of deficiency…

In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects. Areas Covered in the Seminar: - The historical background of why the GCP standards were developed. - The concept of and the purpose of ”GCP”. - The twelve ICH Principles of “GCP”. - The ICH definition of “GCP” and how it is applied. - The Regulatory requirements to follow to be GCP compliant. - Who, in the clinical research team is responsible that GCP is followed? - How to be sure CPU / Site staff know their…

In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them. Areas Covered in the Seminar: . Importance of the Audit Team Coordinator. . Auditor Selection. . Auditor Training Requirements. . Auditor Responsibilities. . Audit Planning. . Pre-audit Preparation. . Audit Performance. . Post-audit Requirements and Tasks. Who Will Benefit: This webinar will provide valuable assistance to all companies that are subject to FDA regulations, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: . Top management…

Learn key factors affecting shipping and distribution of product and the stability studies that should be done to support shipping and distribution. Areas Covered in the Seminar: - Goal of stability studies. - Warning letters and observations on shipping and distribution practices. - Short term excursion study. - Thermal cycling study. - Analytical testing for these studies. Who Will Benefit: - Pharmaceutical scientists - Manufacturers or raw material and ingredients - Analysts and lab managers - QA managers and personnel - Regulatory affairs

This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being. Areas Covered in the Seminar: - The definition of the “Informed Consent Process” per regulations. - The ethical standards surrounding the informed consent process . - The roles of parties responsible for an adequate ICF process per FDA regulations. - Barriers that affect subjects’ comprehension to the essential elements of the Informed Consent. - The most common deficiencies noted in the Informed consent…

This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements. Areas Covered in the Seminar: FDA inspections: Preparation, conducts, follow up. Scope of the new Part 11 program: time frame, expected outcome. Criteria for selection of target companies. What will inspectors be looking for. How to prepare your company for the upcoming inspections. Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations. How to fill gaps short term. Developing a program for long term. Creating the…

This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Areas Covered in the seminar: . Understand that audit preparation is critical and how to generate the audit plan. . Learn the different type of audits and how to prepare, execute and close out the audit. . Selecting your auditor or audit team and knowing the source of authority for conducting the audits. . Development of checklists and using data collection…

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…

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…

This course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations, described above In this course, you learn how to properly manage FDA during an inspection, how to impact the FDA decision-makers, and how to respond to FDA 483 Observations. In addition, the course will show you how to strategically address compliance issues and avoid a Warning Letter Since FDA continues to crack down on cGMP violators and issuing 483s and Warning Letters as well as ordering shut-downs and investigations for non-compliance, the potential for millions of dollars…