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Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.

Compliance Workshop 111

GMP Compliance for Quality Control and Contract Laboratories

 

Duration: 2 days

Time: 9.00 am to 5.00 p.m.

Fee: US$ 1499

 

Scheduled Public Seminars

Dates 2015

Location

Venu

April 15/16

Boston, MA

TBD

July 30/31

Chicago, IL

TBD

     

Flexible in-house or public seminars

Interested in organizing any in-house or public seminar: at any time, anywhere?

If so, click here

Overview

Quality control and related contract laboratories are considered high risk because after testing and approval drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.

This course provides the regulatory background and guides attendees through all critical areas of GMP compliance. The course not only helps attendees to understand the requirements but also provides templates and examples to develop inspection ready documentation. Practical examples and interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course .

Course objectives

Attendees will:

  1. Learn about the regulatory background and GMP requirements for quality control and contract laboratories
  2. Understand and be able to explain your company’s quality plan or laboratory compliance master plan
  3. Understand the difference between GMP and non-GMP Laboratories
  4. Learn how to develop inspection ready documentation
  5. Be able to train others in your organization on GMP requirements
  6. Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Course Outline Day 1

Session 1: FDA Regulations and Requirements Overview

  • FDA 21 CFR Part 211 and 21 CFR Part 11
  •  Most frequently cited FDA 483s and warning letters
  •  Requirements overview from sampling to archiving
  •  Quality system requirements, e.g., ICH Q10
  • The concept and practice of risk based compliance

Session 2: Planning for quality and cGMP compliance

  • Developing and using a validation master plan
  •  Scope, objectives and key elements of the master plan
  •  Developing and using FDA compliant SOPs
  •  Using templates to generate inspection ready documentation
  •  Planning for efficiency cost-effectiveness

Session 3: Calibration and Qualification of Laboratory Equipment

  • Calibration and Qualification of Laboratory Equipment
  •  FDA requirements
  •  USP chapter <1058> for instrument qualification
  •  Going through examples for qualification steps: DQ, IQ, OQ, PQ)
  •  SOPs and deliverables for three instrument categories
  •  Developing calibration and qualification protocols

Session 4: Equipment Maintenance and Change control

  • Preventive maintenance; tasks, documentation
  •  Planned and unplanned changes
  •  Changing hardware, firmware, documentation
  •  Definition and handling of like-for-like changes
  • Requalification: time and event based

Session 5: Validation of Laboratory Computer Systems

  • Going through the new GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
  • Going through a complete laboratory computer system validation from beginning to end
  • Integrating the GAMP® guide with USP <1058>
  • Periodic evaluation to reduce revalidation efforts
  • Revalidation: why, what, when

Session 6: Validation of Analytical Methods and Procedures

  • Parameters and tests according to ICH Q2
  • Developing a validation plan, protocols and a report
  • Setting acceptance criteria for different applications
  • Verification of compendial methods according to USP <1226>
  • Transfer of analytical procedures according to the new USP <1224>

Course Outline Day 2

Session 7: Sample Testing: Preparation, conduct, documentation

  • Preparing the equipment:
  • Setting specifications and acceptance criteria
  • Documentation of test results
  • Review and approval
  • Not to forget: Review of electronic audit trail

Session 8: Handling out of specification(OOS) test results

  • Going through the FDA OOS guide
  • Learning from recent FDA warning letters
  • Going through an OOS checklist
  • Using out of trend (OOT) data to avoid OOS results
  • Documentation and follow-up: root cause, corrective action plan, preventive action plan

Session 9: Quality assurance of reference standards and other supplies

  • Supplier qualification vs. sample testing
  • Selection and assessment of suppliers
  • Retesting of materials
  • Preparing working standards from reference standards
  • Correct labeling of chemicals

Session 10: Training for GMP compliance

  • Supplier qualification vs. sample testing
  • Selection and assessment of suppliers
  • Retesting of materials
  • Preparing working standards from reference standards
  • Correct labeling of chemicals

Session 11: Ensuring Integrity of Raw Data and Other records

  • FDA Part 11 and EU-PIC/S Annex 11 requirements
  • Definition of Raw Data: Electronic vs. paper
  • Acquisition and recording of raw data
  • The importance of electronic audit trail
  • Archiving of electronic records for ‘ready retrieval’

Session 12: Internal audits in preparation for FDA inspections

  • Scheduling of audits
  • FDA Inspections as model for laboratory audits
  • Going through a typical FDA laboratory inspection
  • Responding to Typical inspectional/audit deviations
  • How to avoid FDA 483s and warning letters

The Concept of the Interactive Workshops

  • During the workshop practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. At least 50% will be dedicated to practical sessions with life examples. The outcome will be made available for all attendees on a special workshop reference website.
  • After the workshop attendees will have web access to 30+ best practice guides such as master plans, examples, checklists and SOPs. This will enable attendees to easily implement what they have learned 

Who will benefit from the course

By function

  • Analysts and lab managers
  •  QA managers and personnel
  •  Validation specialists
  •  Regulatory affairs
  •  Professionals
  • Human resources (HR) managers and staff
  • Training departments
  •  Documentation department
  •  Consultants. teachers

By industry and organizations

  • (Bio)Pharmaceutical development and quality control
  • Contract laboratories
  • Equipment suppliers and service providers supporting related organizations
  • Consulting firms

What attendees get

  •  Workshop conducted by an internationally recognized compliance expert
  • Industry proven real-life case studies
  • Highly efficient workshop exercises through prefilled templates
  •  Answers to any issues directly by the trainer in an one-on-one interaction
  • Take home SOPs, templates and examples for cost effective implementation
  • Access to the PowerPoint presentations to train others in your company
  • 30 days phone and e-mail post workshop support through the trainer
  • Certificate of training completion
  • Detailed documentation of the trainer's qualificati

More info?

If you are interested in this In-house workshop or in organizing it as public workshop, please click here.

About the speaker: Dr. Ludwig Huber

  • Chairman, presenter and panel discussion member at US-FDA Industry training sessions and conferences
  • Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Systems
  • "Presenter of the Year" of the Institute for Validation and Technology selected out of 170 presenters
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
  • For more information on Ludwig Huber, click here.
Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Free "Best Practice Guides" for GMP compliance in QC and Contract laboratories (all developed by the trainer)

Documents include

  • Primers
    - Compliance by Design for Pharmaceutical Quality Control Laboratories (link)
    - FDA GMP Compliance in Analytical Laboratories (50 pages)
  • 50-page Laboratory Compliance Master Plan (m-133)
  • Step-by-step implementation of GMP laboratory compliance (m-516)
  • Gap Analyses/Worksheets
    1. Drug CGMP Quality System (e-110
    2. Good Manufacturing Practices (e-167)
    3. Auditing Quality Control and Contract Laboratories (e-184)
  •  Standard Operating Procedures
    1. Corrective and Preventive Actions (s-114)
    2. Handling Out-of-Specification Results (s-115)
    3. Handling Out-of-Trend Situations (s-116)
    4. Qualification of Equipment (e-240)
    5. Validation of Spreadsheet Applications (e-264)
    6. Retention and Archiving of Electronic Records (e-315)
    7. Generation and Maintenance of SOPs for Laboratories (S-504)
    8. Change control of analytical equipment (s-509)
    9. Auditing Quality Control Laboratoriesies (s-511-03)
    10. Review and Approval of Analytical Test Results (s-512)
    11. Training for Laboratory Personnel (e-513)
    12. Purchasing and Receipt of Supplies for Laboratories (s-514)
    13. Quality Assessment of Laboratory Suppliers (s-515)
    14. Risk Assessment for Laboratory Systems (e-519)
    15. Laboratory Complaint Handling (s-520)
    16. Subcontracting of Testing and Calibration (s-522)
    17. Laboratory Failure Investigations (e-530)
    18. Preparation of Laboratory Working Standards (s-532)
    19. Handling of Laboratory Test Samples (s-534)
    20. Reserve Samples in Laboratories (s-535) NEW
    21. Maintenance of Laboratory Equipment (S-541)
    22.Validation of Analytical Methods (s-612)
    23  Handling (Certified) Reference Material (s-625)
    24. Calibration of Analytical Balances (s-641)
    25. Qualification of Refrigerators (s-644)
    26. Validation of Laboratory Computer Systems (s-656)

®GAMP is a registered trademark of ISPE and stands for Good Automated Manufacturing Practice