On Demand Webinars
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Recording
4-Hour Virtual Seminar on Aseptic Processing 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... -
Recording
4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and... -
Recording
4-Hour Virtual Seminar on Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong... -
Recording
4-Hour Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
Computer systems used in conducting clinical trials must be evaluated to determine the level of compliance, established on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer... -
Recording
4-Hour Virtual Seminar on Design and Conduct of Clinical Trials – Design Requirements, Statistical Issues, and Clinical Protocols
Clinical trials play a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and... -
Recording
4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions
US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that... -
Recording
4-Hour Virtual Seminar on FDA Inspection Readiness – Be Ready!
Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill... -
Recording
4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts
Nonclinical laboratory studies must comply with the Good Laboratory Practice (GLP) regulations prescribed in Title 21 CFR part 58. This has been crafted to ensure data quality and integrity. These studies support or are intended to support applications for... -
Recording
4-Hour Virtual Seminar on Preparing and Submitting Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications, and Conducting FDA Meetings
A key role is played by what you submit to the regulatory agency, they hold more than just written applications. They also enclose systematic tracking, editing, publishing and strategy of crucial data. Through precise instructions, case studies and first... -
Recording
4-Hour Virtual Seminar on Project Management for Non-Project Managers
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
Recording
4-Hour Virtual Seminar on Quality Control Laboratory Compliance – cGMPs and GLPs
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as... -
Recording
4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
Computer system validation (CSV) relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA has been regulating CSV for more than 30 years now.... -
Recording
4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Duration: 4 Hours
Presenter: MICHAEL ESPOSITO -
Recording
4-Hour Virtual Seminar on Statistical Process Control
Statistical process control (SPC) is a form of feedback process control that does for discrete products what automatic process control does for the chemical process industry. Its purpose is to distinguish special or assignable causes from random or common... -
Recording
4-Hour Virtual Seminar on Write SOP’s and Work Instructions that Really Work
This seminar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business and the functions comprising it. Writing Standard Operating Procedures and Work Instructions is technical... -
Recording
4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could...
