GLP/cGMP for Testing Laboratories Webinar
This webinar will cover the history and practical basics of GLP training and cGMP training (combined referred to as GxP) for analytical testing laboratories. The intent is to introduce the student to what a GLP Study is, the basic steps, intentions, and goals of the US FDA Regulation training and world standards, and how industry uses GxP Analytical and Animal Testing.
The goal is for each student to understand his or her potential role(s) in a study and what might be expected of them in industry or in an academic setting.
For each lecture topic listed below, industry examples and sample FDA warning letters will be used.
General Introduction and GxP compliance, history, study use, key terms and personnel
The different uses of GLP and cGMP Testing
Protocols and Reports
Data and analysis integrity, review and archiving
Out of Trend, Out Of Specifications
Deviations, Corrective Actions, and Amendments
FDA inspections and Sponsor audit preparation
Why Should You Attend
Contract Research Organizations and Analytical Laboratories are becoming more scrutinized by regulatory authorities and methods and resulting data integrity more important. Get things right from the beginning of your study or testing by defining what needs to comply with GLP or cGMP regulations.
If you are responsible for a testing laboratory and are running both GLP and cGMP testing, use this training to help define what level of compliance is necessary or expected.
Areas Covered In This Webinar
The history and practical basics of a Good Laboratory Practice (GLP) study and current Good Manufacturing Practice (cGMP) for analytical testing laboratories and to introduce the student to what a GxP Study is, the basic steps, intentions, and goals of the US FDA Regulations and world standards, as well as how industry uses GxP Analytical and Animal Testing.
Learning the practical basics of a Good Laboratory Practice (GLP) study and current Good Manufacturing Practice (cGMP) for analytical testing laboratories
To introduce the student to what a GxP Study is, the basic steps, intentions, and goals of the US FDA Regulations and world standards, as well as how industry uses GxP Analytical and Animal Testing
The goal is for each student to understand his or her potential role(s) in a study and what might be expected of them in industry or in an academic setting
Who Will Benefit
Quality Assurance Professionals
Cinta Burgos has been involved in the Biotech and Medical Device industry and medical research for over 20 years; working in various positions in research engineering, validation engineering, and Quality Assurance in large companies as well as small start-ups. Prior to entering the industry she was a microbiology laboratory researcher. The Biotech Box Consulting was Co-founded in 2014 to establish a base for pre-packaged solutions (SOPs, forms and templates) and well as out-of-the box consulting. Cinta operated CB Biotech Consulting from 2003-2013, supporting GLP and GCP laboratories and studies; developing and maintaining Quality Systems from Design Control/Product Development to cGMP manufacturing; conducting ISO, GMP, and GCP audits, managing complaint, risk, and corrective action systems, training, due diligence, and regulatory submission support. She has audited and supported small start-ups as well as in large, global companies. Cinta has a BS in BioPhysics from UCSan Diego, has completed graduate student level work in Mechanical Engineering, is currently on the Board of Directors of ASQ Biomedical NEDG, and is an active member of SWE.
Some products Cinta has helped support or bring to market are pacemakers, stents, oxygenators, filled vial automatic systems, blood substitutes, biosimilars, vena cava filters, neuro shunts and clips, monoclonal antibodies, cell separation, embolotherapy, heart monitoring equipment, IVD, combination devices, medical mobile apps, direct to consumer cosmetic electronic and software controlled systems.
Specialties: Validations; FMEA/Risk Management; Quality Systems and Documentation; Complaints; Design Control; Training; Internal, Supplier, and Clinical Audits.