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

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

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

Who Will Benefit

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.

Karl M. Nobert (25+ yrs exp)

Senior Counsel Michael Best & Friedrich LLP - USA

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.

Choose a Purchase Option


$1,495

One Dial-in One Attendee - Live + 6 month Access

You get one log-in for the live virtual seminar for one participant & On Demand Recorded Access for 90 days , presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access for 30 days is included .

$4,995

Group-Max. 10 Attendees - Live + 12 month Access

You get Group log-in for the live virtual seminar for 10 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 90 days for the Group.

$1,496

Recorded Access Single Participant

You'll have 6 month access to single log-in for an archived recording of the entire 3 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$4,998

Recorded Access Group-Max. 10 Attendees

You'll have 12 month access to group log-in upto 10 attendees for an archived recording of the entire 3 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Our Past Seminar Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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