Food, Drugs & Biologics
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U.S. FDA’s Strategic Priorities – 2015 and Beyond
Description: This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety. Each year companies are to perform a complete review of their quality... -
Risk Management in Clinical Trials
Description: ICH Q9 – Quality Risk Management has been present as an FDA Guidance Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical... -
Risk-based Outsourcing
Description: The regulatory background for the Pharmaceutical industry as a whole now requires a ‘risk based approach’ to all activities and that will of course include Outsourcing. Lack of Outsourcing Oversight is a very common finding during audits and... -
Computer System Validation
Description: This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation. Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but... -
Expanding Your Quality Toolbox using a Risk Based Approach
Description: The awareness and use of data is a direct reflection of the maturity of a company’s management system. Quality Tools are the lens, collectors and sifters through which we interact with our data. In this workshop we will... -
Transition to ISO 9001:2015 with Confidence
Description: The publication of ISO 9001:2015 and its impact on many related industry-specific standards will present a unique opportunity for organizations to evaluate and improve their existing QMS. With the publication of ISO 9001:2015, organizations now face the next... -
Application of Lean Six Sigma Methodology for Regulated Industries
Description: This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. Participants will learn each phase of Six Sigma’s DMAIC methodology and their use as a part... -
Risk Based Quality Auditing
Description: Risk Elimination. Risk Management. Risk Mitigation. This is the language of upper management, that we as auditors from any industry must learn, if we truly want to effect positive change throughout our environment. During this presentation, the various... -
Root Cause Analysis and Corrective Action
Description: This course not only looks at root cause analysis through the lens of identifying deficiencies that need elimination but also from the standpoint of how root cause analysis can be used to drive continuous improvement. Learn why problems... -
Risk Based Auditing
Description: Risk Elimination. Risk Management. Risk Mitigation. This is the language of upper management, that we as auditors from any industry must learn, if we truly want to effect positive change throughout our environment. During this presentation, the various... -
The FDA Good Manufacturing Practices (GMP) for Drugs and Biologics
Description: This webinar is a must for those personnel that require an understanding of the regulation governing manufacturing operations. FDA’s regulates the manufacture of Drugs and Biologics under the Good Manufacturing Practices (GMP) regulation 21 CFR Parts 210-211. FDA... -
Good Laboratory Practice Regulations
Description: This web seminar presents an overview of FDA’s GLP regulation – 21 CFR Part 58. The FDA GLP regulation complies with all GLP requirements globally. This web seminar covers every section of the FDA GLP regulation, offers FDA... -
FDA Approval Process for Combination Products
Description: This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the... -
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FDA’s Biosimilar (Generic Biologics) Process
Description: This web presentation presents an overview of FDA’s requirements for approval/marketing of a Generic Biologic (Biosimilar) in the USA. This webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The webinar also... -
GCP/GLP/GMP : Comparison of FDA’s 3 Major Regulations
Description: These are the 3 major regulations FDA uses to regulate the Pharmaceutical/Medical Device industries in the USA. This web presentation presents an overview of FDA’s 3 major regulations – Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and... -
Part 11 Compliance and the Role of Standard Operating Procedures
Description: 21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However,...
