Food, Drugs & Biologics
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ANDA Submission and GDUFA Final FDA Guidance
Just as everyone was beginning to get conversant with GDUFA’s confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying... -
ANDA Submission and GDUFA Final FDA Guidance
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA’s Center for Drug... -
Annex 1 Manufacture of Sterile Medicinal Products
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture... -
Applying Computer System Validation to Mobile Applications
Mobile applications can be validated as per FDA regulations using the same principles of computer system validation. For this to be compliant, development of an appropriate validation strategy to achieve the diligence required to prove that a system does... -
Artificial Intelligence in Pharmaceutical GMP Operations – Case Studies
This latest webinar will showcase possibilities with some case study examples of what can be done. The case study for manufacturing, maintenance, instrumentation, Quality assurance and regulatory assurance functions will be discussed. It is a must attend webinar to... -
Aseptic Process Overview and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a... -
Aseptic Process Simulations – A Comprehensive Guide for Proper Execution
Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. An Aseptic Process Simulation is... -
Aseptic Processing and Techniques 101
Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our... -
Assay Validation For Clinical Diagnostics
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use. On a regular basis, there are assays that get developed that have... -
Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with...