Industries: Pharma / Biotech

Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer

Course Director: Steven A. Ostrove, Ph.D.

Course Description - Course runs 9:00 to 5:00 both days

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

This two-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 Agenda

First Day

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

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)

Second Day

Auditing – Validation-Improvement

Session 4-The Regulatory Inspection

  • Planning, techniques, reporting and follow-up actions
  • Self-Inspection and Self-Auditing
  • Auditing external QC labs

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

Session6-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

Learning Objectives

This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance including:

  • General requirements for design and construction of analytical laboratories
  • Calibration and Qualification of instrumentation and equipment
  • Documentation, records-keeping and change control
  • Management of reagents, test solutions and reference standards
  • Personnel development and training

Testimonials

"Dynamic presentation style kept my interest. Practical examples were really useful in making course material relevant. Length of course was good; not too long and not too condensed. Course material was well developed and nicely presented for attendees." Diana B., QC Chemistry Manager, Allergan
"The instructor was extremely energetic and maintained focus of the entire group at all times. Never once did I look at my watch to see how much longer we had to go. He was extremely well versed in all areas and offered appropriate examples to drive home all key concepts." Lauren B., Project Manager, Chiron
"The course was very informative and lots of useful information was presented. The instructor handled a number of difficult questions and I learned a great deal from others in the course." John M., Quality Manager, Berlex
"The material and speaker was great. I liked the examples that he used to convey the material. I appreciated allowing as many students' questions as he did. The recommendation given to read the secondary materials; such as website literature, court cases, and guidance documentation was very helpful. I would look for more classes to take from this course director and company again." Kristi C., Lab Technician