DUBLIN, July 20, 2021 /PRNewswire/ — The “Basic GMP Training for the QC Laboratory” conference has been added to ResearchAndMarkets.com’s offering.
This three-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control laboratories.
The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance.
This course will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations and Corrective and Preventive Actions.
Course Description
Upon completion of this course, you will:
- Be conversant in the specialized language of laboratory compliance
- Be very familiar with the cGMPs and other regulations as they impact QC labs
- Know the current compliance “hot spots” that FDA and other regulatory authorities look for when inspecting QC labs
- Understand how to effectively deal with laboratory deviations and OOS results
- Have an understanding the what, how and why of laboratory equipment qualification and methods validation
- Understand how to properly prepare your QC lab for audits and inspections
Who Should Attend:
Agenda:
Day 1 Agenda
Regulations – Guidance’s-Problems
Session 1 – Introduction to Laboratory GMPs
- Introduction
- Overview of CFR Title 21, Parts 58, 210 and 211, an abbreviation and acronym primer
- Differences between Part 58 and Part 211
- The Design of a Quality Control Laboratory:
- Part 211 Subpart C: Buildings and Facilities
- Utilities
- Equipment and Instrumentation-Subpart D: Equipment
Session 2 – The GMP Laboratory
- The Essentials of CGMP compliance Laboratory Management-Subpart J: Records and Reports
- Essential Documentation Sample management-Subpart E: Control of Components and Drug Product Containers and Closures
- Good Documentation Practices (GDP)
- Stability
- Training
Day 2 Agenda
Session 3 – When Things Go Wrong
- Using the guidance documents
- Deviations and test failures, Subpart F: Production and Process Controls
- Effective Investigations
- A basic root cause analysis primer
- Corrective and Preventative Actions (CAPA)
- Auditing – Validation-Improvement
Session 4 – The Regulatory Inspection
- Planning, techniques, reporting and follow-up actions
- Self-Inspection and Self-Auditing
- Auditing external QC labs
Day 3 Agenda
Session 5 – Laboratory Validation and Other Quality Concerns
- Analytical method validation
- Equipment Qualification Requirements
- Qualification of QC lab equipment: D/I/O/PQ
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- System Suitability Testing: an essential component of lab compliance
- Calibration and maintenance of QC lab equipment
- 21 CFR Part 11 and the QC lab
Session 6 – The cost of non-compliance-Hot Topics
- Examples of Observation of non-compliances – FDA 483
- Top CGMP problems FDA sees in QC labs
- Warning Letters and current hot topics in lab compliance
- Improving operations
- Discussion Forum:
- Question and Answer Period, Course wrap-up and conclusions
- What are your top lab compliance challenges, issues, and problems?
- Discussion of participant questions, problems, and issues
Speakers:
Karl M. Nobert
Michael Best & Friedrich LLP
Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.
He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.
For more information about this conference visit https://www.researchandmarkets.com/r/3mgqob
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
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SOURCE Research and Markets
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