Engaged. Knowledge. Application
Ensuring GLP Quality CONTENT Package
Package includes six (6) content elements, including one (1) webinar recording with PowerPoint presentation, a two-part article series with PowerPoint and trainer instructional notes:
➢ 1. The Brass Tacks of GLP – Practical Understanding of the Fundamentals As Never Before Explained (One Hour Webinar Recording)
➢ 2. The Brass Tacks of GLP – Practical Understanding of the Fundamentals As Never Before Explained (PDF PowerPoint Training Presentation)
➢ 3. Managing Effective Nonclinical QA Programs - Part I (Reference Article)
➢ 4. Managing Effective Nonclinical QA Programs - Part II (Reference Article)
➢ 5. and 6. Managing Effective Nonclinical QA Programs (PDF PowerPoint Training Presentation and Trainer Instructional Notes)
1. & 2. The Brass Tacks of GLP – Practical Understanding of the Fundamentals As Never Before Explained (One Hour Webinar Recording & PowerPoint Training Presentation)
Industry veteran Celeste Rose reviews the fundamentals of GLP in this one hour webinar. She provides numerous examples of critical points of emphasis.
➢Fundamental Principles of GLPs
Control/accountability
Clear study design/objectives
Prevention of contamination/mix-up or deterioration
Data quality & integrity
Accurate results/conclusions
Reconstructibility
➢Control/Accountability
Management responsibilities
Study director
QA unit
GLP personnel
➢Study design/Plan
➢Scheduling
➢Contamination, mix-up or deterioration
➢Test material integrity
➢Reagent material integrity
➢Test system integrity
➢Specimen/sample integrity
➢Data quality & integrity
➢Deviations
➢FDA BA/BE concerns
➢Reconstructibility
➢FDA 483 findings reviewed include:
Personnel documentation 58.29
Study Director 58.33
Protocol 58.120
SOPs 58.81
Equipment 58.63
Study reports 58.185
2. The Brass Tacks of GLP – Practical Understanding of the Fundamentals As Never Before Explained (PDF PowerPoint Training Presentation)
This 54 slide PDF PowerPoint Training Presentation is based on the subject matter presented in the webinar training above.
3. Managing Effective Nonclinical QA Programs - Part I (Reference Article)
This 30+ page two-part series provides a comprehensive review of critical aspects of an effective nonclinical QA program, including the Quality Assurance Unit (QAU). Part 1 provides an historical perspective of events that gave birth to the GLP regulations in the 1970s.
This series discusses the following GLP compliance subject matter areas, including:
➢Drug development cycle
➢Toxicology studies and the IND
➢Types of nonclinical studies
➢GLP regulations
➢GXP quality assurance roles and responsibilities
➢Origin of the GLP and QA Unit
➢Observations from FDA’s surveillance audits conducted in the mid-1970s
➢Basis for GLP
➢Role of QA under GLP
➢Quality Assurance Unit personnel qualifications
➢QAU responsibilities
➢Master schedule
➢Master schedule and CROs
➢Nonclinical study “phases” and QAU inspections
➢ Documentation of QAU inspections
➢FDA’s position on inspecting a nonclinical study testing facility’s internal audit reports
➢FDA’s bioresearch monitoring program and principles of “ALCOA”
➢GLP audit design using risk management
➢Proper QAU inspection of each phase of a nonclinical laboratory study
4. Managing Effective Nonclinical QA Programs - Part II (Reference Article) Part II of this two-part series reviews the nonclinical study quality plan, including:
➢Protocol review
➢Test article characterization and stability
➢In-phase assessment
➢Data integrity assessment
➢ Draft study report assessment
➢Audit results reporting
➢QA compliance statement issuance (includes an example)
➢The conduct of system-based inspections by the QAU
Components of the GLP quality management system
➢Use of CAPA in the management of GLP quality issues
➢Corrective Action
➢Identifying deviations
➢ Documenting deviations (includes a GLP deviation form example)
➢Investigating deviations
➢Assessing risk
➢Recommendations for corrections
➢Preventative action
***Article also includes a five (5) page Agenda for Audit of Nonclinical CRO by the Study Sponsor QAU (Example)…and more!***
5. and 6. Managing Effective Nonclinical QA Programs (PDF PowerPoint Training Presentation and Trainer Instructional Notes)
20 slide PDF PowerPoint Training Presentation. Based on the subject matter presented in the reference content article series above. This PDF readymade presentation provides “core” subject matter content, and allows you to customize specific information within your presentation.
Trainer instructional notes, which contain 30+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.
Ensuring GLP Quality CONTENT Package is only $159.00
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