Building on the success of hugely popular GMP QC Labs Symposium we are pleased to announce the date of the 2014 event: 9 April 2014, London.
This event will provide professionals working in and with contract quality control testing laboratories with guidance to help them meet EU GMP requirements.
Event Objectives
The objectives of this conference are to provide guidance on ways of attaining best regulatory practice and to review the quality management tools available to increase laboratory throughput whilst maintaining data quality. This conference will address GMP requirements for GMP QC laboratories and it will also present tools for an efficient and effective laboratory operation.
Target Audience
Individuals working for GMP QC testing laboratories contracted to conduct release testing of medicinal products, intermediates or active pharmaceutical ingredients.
Individuals within the Pharmaceutical Industry responsible for contracting out tests related to medicinal products (including intermediates and active pharmaceutical ingredients) and their subsequent assessment as fit for purpose.
This conference will be of significant value to
Laboratory managers
Quality control managers
Analytical scientist
Senior laboratory staff who are responsible for GMP compliance and Laboratory Organisation.
Background
The MHRA is planning to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current manufacturing quality control and pharmacopoeial practices. This event will provide a platform for cross-collaboration and discussion between Industry, International Pharmacopoeia Authorities and International Regulators. Topics covered at the event will include Good Pharmacopoeial Practices and Good Manufacturing Practice in Quality Control Laboratories. We also hope to touch on some of the latest technological developments in pharmaceutical world, such as Biologicals / Biosimilars, Quality by Design (QbD) or Harmonisation.
The conference will also provide an excellent platform for training, information sharing and a chance to understand what is changing in the regulatory landscape.
Benefits/Why Attend
Gain guidance on the investigation of out of specifications
Obtain information on the licensing process for naming of contract GMP QC laboratories
Receive guidance on the application of EU GMP to contract GMP QC laboratories
Highlight key quality critical areas e.g. reconstruction of data
Investigate commonly seen GMP deficiencies
Discover an overview of the expectations for contract QC testing laboratories and the responsibilities of both contract giver and contract acceptor.
Meet the regulator and have the opportunity to ask questions on aspects affecting your organisation.
Gain greater knowledge of the quality issues affecting your organisation
Improve your organisations compliance through learning about enhanced processes
Recognise commonly seen GMP deficiencies and learn how to reduce them in your organisation
Discover what you peers are doing through managed workshop
Delegates will have opportunity to network with their peers over a common area of discussion, debate hot topics and have your questions answered by the Regulatory body and /or the Pharmacopoeial Authority.
This event will provide professionals working in and with contract quality control testing laboratories with guidance to help them meet EU GMP requirements.
Event Objectives
The objectives of this conference are to provide guidance on ways of attaining best regulatory practice and to review the quality management tools available to increase laboratory throughput whilst maintaining data quality. This conference will address GMP requirements for GMP QC laboratories and it will also present tools for an efficient and effective laboratory operation.
Target Audience
Individuals working for GMP QC testing laboratories contracted to conduct release testing of medicinal products, intermediates or active pharmaceutical ingredients.
Individuals within the Pharmaceutical Industry responsible for contracting out tests related to medicinal products (including intermediates and active pharmaceutical ingredients) and their subsequent assessment as fit for purpose.
This conference will be of significant value to
Laboratory managers
Quality control managers
Analytical scientist
Senior laboratory staff who are responsible for GMP compliance and Laboratory Organisation.
Background
The MHRA is planning to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current manufacturing quality control and pharmacopoeial practices. This event will provide a platform for cross-collaboration and discussion between Industry, International Pharmacopoeia Authorities and International Regulators. Topics covered at the event will include Good Pharmacopoeial Practices and Good Manufacturing Practice in Quality Control Laboratories. We also hope to touch on some of the latest technological developments in pharmaceutical world, such as Biologicals / Biosimilars, Quality by Design (QbD) or Harmonisation.
The conference will also provide an excellent platform for training, information sharing and a chance to understand what is changing in the regulatory landscape.
Benefits/Why Attend
Gain guidance on the investigation of out of specifications
Obtain information on the licensing process for naming of contract GMP QC laboratories
Receive guidance on the application of EU GMP to contract GMP QC laboratories
Highlight key quality critical areas e.g. reconstruction of data
Investigate commonly seen GMP deficiencies
Discover an overview of the expectations for contract QC testing laboratories and the responsibilities of both contract giver and contract acceptor.
Meet the regulator and have the opportunity to ask questions on aspects affecting your organisation.
Gain greater knowledge of the quality issues affecting your organisation
Improve your organisations compliance through learning about enhanced processes
Recognise commonly seen GMP deficiencies and learn how to reduce them in your organisation
Discover what you peers are doing through managed workshop
Delegates will have opportunity to network with their peers over a common area of discussion, debate hot topics and have your questions answered by the Regulatory body and /or the Pharmacopoeial Authority.
