Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

39
Days Left To REGISTER
Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Why you should attend

Compliance with pharmaceutical GMP regulations is essential for companies manufacturing or testing drugs or drug products for human/veterinary use.  This course provides an overview of the principal GMP requirements relating to facilities/utilities, equipment, documentation and personnel.  It includes approaches for the successful conduct of supplier audits and regulatory inspections.  Course outcomes will be reinforced by a number of group exercises.

Who Will Benefit

This course is intended for personnel involved in pharmaceutical manufacturing in a production, quality assurance or quality control function.

Agenda

Day 1 Schedule

Lecture 1: Essential elements of GMP:

  • Historical background
  • Overview of GMP requirements
  • Organizational units and key roles
  • Buildings and facilities
  • Where to find current information and guidance
  • International harmonization
  • Pharmacopeias
  • Quality risk management
  • Exercise - finding answers to GMP questions

Lecture 2: Equipment, Processes and Materials

  • Validation master plan
  • Validating processes - US FDA guidance
  • Qualifying equipment - risk-based approach
  • Laboratory equipment and computerized data systems - Good Automated Manufacturing Practice (GAMP) classification
  • Control of materials
    • Specifications for raw materials, in-process materials and finished products
    • Approval, rejection and quarantine
    • Suppliers' documentation in respect of bovine spongiform encephalopathy (BSE)/transmissible spongiform encephalopathy (TSE) and residual solvents
  • Exercise - categorizing equipment according to GAMP

Day 2 Schedule

Lecture 1: Documentation and the Pharmaceutical Quality System

  • ICH Q10 - Pharmaceutical quality system
  • Quality manual
  • Standard operating procedures
  • Analytical procedures
  • Production records
  • Equipment records
  • Document control
  • Personnel records
  • Out-of-specification (OOS), out-of-trend (OOT) investigations and deviation reports
    • Determining root cause
    • Corrective and preventive actions

Lecture 2: Audits and Regulatory Inspections

  • The audit process - planning, documentation and corrective actions
  • Internal audits
    • Audit schedule
  • Supplier audits
    • Supplier categories
    • The approved supplier list
  • Regulatory inspections
    • Examples of regulatory inspection observations
  • Exercise - audit planning

Lecture 3: Introduction to Pharmaceutical Data Integrity

  • Historical background
  • Current guidance
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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

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Mark Powell 

Director,
Mark Powell Scientific Limited


Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

He also provides training services, which are accredited by the UK's vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

Venue

Location: London, UK
Hotel: London Hilton on Park Lane