Basic GMP Training for the Quality Control Laboratory: Three-Day Online Course (August 11-13, 2021) – ResearchAndMarkets.com


DUBLIN – (BUSINESS WIRE)–The “Basic GMP training for the quality control laboratory” the conference has been added to ResearchAndMarkets.com from offer.

This three-day course is designed for anyone who works, supervises or participates in the management of pharmaceutical, biopharmaceutical and biological quality control laboratories.

The course will also benefit entry-level quality assurance professionals and others who audit quality control laboratories or whose responsibilities include ensuring laboratory regulatory compliance.

This course will also enable participants to understand how to effectively manage non-to-specification results, deviations, laboratory investigations, and corrective and preventive actions.

Description of the course

At the end of this course, you:

  • Know the specialized language of laboratory compliance

  • Be very familiar with cGMP and other regulations as they impact quality control laboratories

  • Know the current compliance “hot spots” that the FDA and other regulatory authorities look for when inspecting quality control laboratories

  • Understand how to effectively manage lab deviations and OOS results

  • Have an understanding of the what, how and why of laboratory equipment qualification and method validation

  • Understand how to properly prepare your quality control lab for audits and inspections

Who should be present:

Agenda:

Agenda for day 1

Regulations – Orientation issues

Session 1 – Introduction to laboratory GMP

  • introduction

  • Overview of Title 21 CFR, parts 58, 210 and 211, an abbreviation and an abbreviated acronym

  • 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 Pharmaceutical Components and Containers and Closures

  • Good Documentation Practices (PIB)

  • Stability

  • Training

Agenda for day 2

Session 3 – When things go wrong

  • Use of guidance documents

  • Test Deviations and Failures, Subpart F: Production and Process Controls

  • Effective investigations

  • A basis for root cause analysis

  • Corrective and preventive actions (CAPA)

  • Audit – Validation-Improvement

Session 4 – Regulatory inspection

  • Planning, techniques, reporting and follow-up actions

  • Self-inspection and self-audit

  • Audit of external quality control laboratories

Agenda for day 3

Session 5 – Laboratory validation and other quality issues

  • Validation of the analytical method

  • Equipment qualification requirements

  • Qualification of QC laboratory equipment: D / I / O / PQ

  • Design qualification

  • Installation qualification

  • Operational qualification

  • Performance qualification

  • System suitability testing: an essential part of laboratory compliance

  • Calibration and maintenance of quality control laboratory equipment

  • 21 CFR Part 11 and the QC lab

Session 6 – The cost of non-compliance – Hot topics

  • Examples of observation of non-conformities – FDA 483

  • Top CGMP Problems Found by FDA in Quality Control Laboratories

  • Warning letters and hot topics in laboratory compliance

  • Improved operations

  • Discussion forum:

  • Question and answer period, course summary and conclusions

  • What are your top lab compliance challenges, issues and concerns?

  • Discussion of participants’ questions, issues and concerns

Loudspeakers:

Karl M. Nobert

Michael Best and Friedrich LLP

Karl focuses his practice in FDA regulatory law, representing U.S. and international clients in the food and pharmaceutical industries with respect to pharmaceuticals and over-the-counter drugs, biologics, medical devices, foods, and pharmaceuticals. beverages, including dairy products, cosmetics, vitamins and food supplements, and veterinary products. .

He has particular experience in the fields of prescription drugs and regenerative medicine, and has advised numerous clients seeking FDA approval for Rx drugs and cellular products to treat both humans and animals.

For more information on this conference, visit https://www.researchandmarkets.com/r/214cs4


About Hector Hedgepeth

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