ComplianceOnline

Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the 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 two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.

Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will 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 from the course.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

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

Complimentary Hand-outs (Value US$ 649.00):

For easy implementation, attendees will receive free access to “Laboratory Compliance Package” as Web download.

This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories (Value: US$ 649)

  • 50-Page primer: FDA GMP Compliance in Analytical Laboratories
  • Laboratory Compliance Master Plan
  • Worksheet – Laboratory Audits
  • Following 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 Analytical Laboratories (s-511)
  1. Review and Approval of Analytical Test Results (s-512)
  2. Training for Laboratory Personnel (e-513)
  3. Purchasing and Receipt of Supplies for Laboratories (s-514)
  4. Quality Assessment of Laboratory Suppliers (s-515)
  5. Risk Assessment for Laboratory Systems (e-519)
  6. Laboratory Complaint Handling (s-520)
  7. Subcontracting of Testing and Calibration (s-522)
  8. Laboratory Failure Investigations (e-530)
  9. Preparation of Laboratory Working Standards (s-532)
  1. Handling of Laboratory Test Samples (s-534)
  2. Reserve Samples in Laboratories (s-535) NEW
  3. Maintenance of Laboratory Equipment (s-541)
  4. Validation of Analytical Methods (s-612)
  5. Validation of Chromatographic Methods (s-613)
  6. Handling (Certified) Reference Material (s-625)
  7. Calibration of Analytical Balances (s-641)
  8. Qualification of Refrigerators (s-644)
  9. Validation of Laboratory Computer Systems (s-656)

Who Should Attend:

This seminar will be beneficial to the following personnel in FDA regulated laboratories:

  • Analysts and lab managers
  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • IT professionals
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants& teachers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 09:00 - 09:45: 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
  • 09:45 - 10:30 (*): 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
  • 10:30 - 11:00: Break
  • 11:00 - 12:00 (*): 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
  • 12:00 - 12:30 (*): 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
  • 12:30 - 13:30: Lunch
  • 13:30 - 15:00: 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
    • Integration the GAMP® guide with USP <1058>
    • Periodic evaluation to reduce revalidation efforts
    • Revalidation: why, what, when
  • 15:00 - 15:30: Break
  • 15:30 - 17:00 (*): 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>
Day 02(8:30 AM - 4:30 PM)
  • 08:30 - 09:00 AM: 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
  • 09:00 - 10:00 (*): 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
  • 10:00 - 10:30: Break
  • 10:30 - 11:15 (*): 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
  • 11:15 - 12:00: Training for GMP compliance
    • FDA requirements
    • identification of training needs
    • Developing a training plan
    • Making GMP training interesting
    • Documenting effectiveness of training
  • 12:00 - 13:00: Lunch
  • 13:00 - 14:30 (*): 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’
  • 14:30 - 15:00: Break
  • 15:00 - 16:15 (*): Internal audits in preparation for FDA inspection
    • Scheduling of audits
    • FDA Inspections as model for laboratory audits
    • Going through a typical FDA laboratory inspection
    • Responding to Typical inspectional/audit deviation
    • How to avoid FDA 483s and warning letters
  • 16:15 - 16:30: Wrap up – Final questions and answers
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Dr. Ludwig Huber

Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, Labcompliance

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

For more information, visit www.ludwig-huber.com

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$1,699.00

Seminar One Registration (USD)

December 5-6, 2017, Amsterdam, Netherlands
(Registrations till September 20, 2017 - $1699)
(Registrations till October 25, 2017 - $1999)
(Registrations after October 25, 2017 - $2099)

$2,099.00

Seminar One Registration (USD) (With 2 Nights Stay)

December 5-6, 2017, Amsterdam, Netherlands

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December 5-6, 2017, Amsterdam, Netherlands
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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Location:

Amsterdam, Netherlands
(Venue to be announced shortly)

December 5-6, 2017

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Testimonials

See What People Say About Us

Dr. Huber is very knowledgeable and the supporting material provided by him is very helpful.

SQA Compliance Auditor,

AbbVie Inc.

There is sufficient information in the seminar and the presenter is very professional.

Head of Quality,

Bayer HealthCare.

Definition of raw data and its relationship of e-signature application topic was most valuable to me as we were evaluating the gap in our company and this handy data before doing that will help us to get the requirement.

Assistant Manager,

QA, SHL Group Limited

Information and resources provided by Dr. Huber is very informative. Additional resources provided by him has practical and applicable approach. What I have learned will be helpful in reinforcing compliance in the company with QA.

Assistant Manager,

Quality Assurance, EirGenix, Inc

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Amsterdam, Netherlands

Rijksmuseum

Rijksmuseum

The Rijksmuseum is a Dutch national museum dedicated to arts and history in Amsterdam in the Netherlands. It is the largest museum in the Netherlands, with more than a million visitors each year. s exhibition called The Masterpieces shows the most famous pieces of Dutch art from the 17th c., usually called the Golden Age of the Netherlands.

Rembrandtplein (Rembrandt Square)

Rembrandtplein (Rembrandt Square)

Rembrandtplein is one of the busiest squares in the city, at least when it comes to nightlife and clubbing. It is lined with pubs, restaurants, cafes and hotels and is thus a tourist magnet. A popular centre for nightlife, it also includes traditional Dutch pubs which play real Dutch music. Around the area you’ll also find quality night clubs, gay venues, respectable diamond dealers and the inevitable tacky souvenir shops.

Albert Cuyp market

Albert Cuyp market

The Albert Cuyp market is arguably the best-known and busiest outdoor market in Europe. It attracts thousands of visitors every day, and is especially popular on Saturdays. There are over 300 stalls and goods range from fresh produce, to clothes, to odds and ends, with prices among the cheapest in Amsterdam.

Vondelpark

Vondelpark

Vondelpark is the largest city park in Amsterdam, and certainly the most famous park in the Netherlands, which welcomes about 10 million visitors every year. The Vondelpark is centrally located south of Leidseplein and near Rijksmuseum, Stedelijk Museum and Van Gogh Museum.

Oude Kerk

Oude Kerk

This old church with little houses clinging to its sides, remains a calm heaven at the heart of the freneric Red Light District. Its buildings, especially the Gothic-renaissance style octagonal bell tower, were used by sailors to get their bearings.

Magere Brug

Magere Brug

Of Amsterdam's 1280 or so bridges, the Magere Brug, or “Skinny Bridge” is the most famous. It is a traditional double-leaf, Dutch draw-bridge connecting the banks of the river Amstel. Approximately every twenty minutes, the bridge opens to let boats through.

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