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Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703396
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
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Verification vs. Validation in FDA Regulated Industries
John Chapman
60 Min
Product Id: 700828
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.
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The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
Eliana Silva de Moraes
3 hrs
Product Id: 705675
Learn marketing authorization process for health products in Brazil with focus on documentation, approval process, labeling, advertising, post marketing vigilance. Understand the health protection goals of the law; Polices to meet the applicable regulations. Learn how to harmonize your regulatory strategy for getting approval at less time and cost. How the agency ANVISA works.
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Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
John E Lincoln
90 Min
Product Id: 704848
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
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Validation and Use of Cloud Computing in FDA Regulated Environments
Dr. Ludwig Huber
75 Min
Product Id: 703423
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
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Stability Programs for Leachable Impurities
Wayland Rushing
60 Min
Product Id: 704685
This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.
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Extractables and Leachables in Early Phase Development
Wayland Rushing
60 Min
Product Id: 704517
This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.
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3-hr Virtual Seminar: The ISO 13485 and ICH-10 Quality Manuals for the FDA Regulated Industry
Howard Cooper
3 hrs
Product Id: 705843
This webinar explains how the ISO 13485 (Medical Devices) & ICH Q10 (Pharmaceuticals) quality manuals create a systematic, formal and collaborative approach for establishing roles, authorities and responsibilities in the planning, development, and implementation of inter-functional cGMP procedures (i.e. Incoming Material Control, Change Control, & Design Control), required by FDA regulations. Particularly applicable are 21 CFR Parts 210-211, Parts 803, 810 & 820, & ICH Q7A. The Quality Manual (QM) synchronizes the law and regulations with quality principles, industry practice, and the writings of “quality gurus”. The organization of the QM’s Table of Contents predicts how well the company understands and practices quality concepts.
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BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?
Robert J Russell
90 Min
Product Id: 705811
This webinar will discuss how to accurately assess the impact of Brexit up on your operations and existing licensed life products in the UK and EU. How to plan to becoming compliant on “what is known” and how to be agile as the rest of implications become clearer. Impact on Filing Registrations with EMA in Q1 2019, How Will the UK’s Withdrawal Effect the Sunset Clause.
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ICH Stability Requirements and Challenges
Wayland Rushing
60 Min
Product Id: 704585
This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.
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Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation
Dr. Ludwig Huber
75 Min
Product Id: 701547
This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.
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5-hr Virtual Seminar: Qualification and Control of Suppliers and Contractors for Pharmaceutical and Medical Device Industries
Howard Cooper
5 hrs
Product Id: 702128
This training on qualification and control of suppliers and contractors in the medical devices and pharmaceutical industry will review compliance requirements, the qualification cycle, the key steps involved in it, including the audit process, use of audit tools and evaluation to decide on qualification/ disqualification.
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Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
Joy McElroy
90 Min
Product Id: 705754
This webinar will discuss the major components of a Validation Master Plans, how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans. It will also highlight the effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans.
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Computer System Validation: Step-by-Step
Dr. Ludwig Huber
75 Min
Product Id: 701673
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
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Medical Device Tracking Requirements
Vanessa Lopez
60 Min
Product Id: 705192
Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
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Good Laboratory Practice Regulations
Dr. Ludwig Huber
75 Min
Product Id: 700204
This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.
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Conducting Effective Quality Audits: Beyond Audit Checklists
Andrew Campbell
60 Min
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
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How to Transition from Paper to Electronic Records in a Regulatory Environment
Charlie Sodano
75 Min
Product Id: 703576
This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.
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Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components
Howard Cooper
115 Min
Product Id: 701944
This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.
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Understanding Disinfectant Qualification Studies - How to avoid errors
Jim Polarine
90 Min
Product Id: 702210
This 90-minute webinar on Disinfectant Qualification Studies will teach you disinfectant testing methodologies, provide examples of disinfectant efficacy tests and show how to troubleshoot problems related to disinfectant efficacy testing.