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2-day In-person Seminar

GMP for Quality Control and Contract Laboratories


January 19th and 20th, 2017

Time: 8:30 AM to 5:00 PM

Singapore

Venue: Mandarin Orchard Singapore


Director : Dr. Ludwig Huber

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  (Without stay)   Price: $1,895.00
(Seminar Fee for One Delegate)

  (With stay)   Includes   Price: $2,295.00
(Seminar Fee for One Delegate)

  Register for 5 attendees (With stay)   Includes   Price: $5,853.00
$11,475.00 You Save: $5,622.00 (49%)*

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 2-day interactive seminar 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


Why should you attend:

  • Learn about the regulatory background and GMP requirements for quality control and contract laboratories
  • Understand details of GMP requirements along the entire sample and data workflow
  • 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, 21 CFR Part 11 and Annex 11 requirements
  • Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Who will benefit:

  • 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
From
  • Pharmaceutical manufacaturers
  • API manufacturers
  • Quality control laboratories
  • Contract laboratories
  • Contract manufacturers
  • Suppliers and service providers of instruments and computer systems

Day 1 Schedule


Lecture 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

Lecture 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

Lecture 3:

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

Lecture 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

Lecture 5:

Validation of Laboratory Computer 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
  • Change control of computer systems

Lecture 6:

Validation of Analytical Methods and Procedures

  • Implementing the new FDA method validation guide
  • 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 USP <1224>

Day 2 Schedule


Lecture 1:

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

Lecture 2:

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

Lecture 3:

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

Lecture 4:

Training for GMP compliance

  • FDA and international requirements
  • Identification of training needs
  • Developing a training plan
  • Making GMP training interesting
  • Documenting effectiveness of training

Lecture 5:

Ensuring Integrity of Raw Data and Other records

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

Lecture 6:

Internal audits in preparation for FDA inspection

  • Understanding FDA and PIC/S inspection guides
  • 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
Seminar Pricing Includes (With stay)
2 Days' Stay
Pick-up and Drop Facility (Nearest Airport)
Breakfast and Lunch
High Tea
Pack of 3 Past Webinars on similar subject
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

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Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Labcompliance

  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as 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 Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
Location: Singapore


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