Dublin, June 23, 2021 (GLOBE NEWSWIRE) -- 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.
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:
Day 1 Agenda
Regulations - Guidance's-Problems
Session 1 - Introduction to Laboratory GMPs
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
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)
Day 2 Agenda
Session 3 - When Things Go Wrong
Using the guidance documents
Deviations and test failures, Subpart F: Production and Process Controls
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
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
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
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/m6ey46
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