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Keys to an Effective Outsourcing Management Policy including classification of suppliers, requirements for evaluation and audits
Overview
Suppliers and vendors play a key role in accomplishing the GMP mandates and it is the firm's responsibility to make sure vendors/suppliers are meeting specifications for the supplied materials, components, equipment and/or services. For many years, industry has implemented procedures for selection, approval and qualification of suppliers and vendors but, in many cases. these were not being implemented effectively or formally documented. Making these programs part of a risk-based quality systems approach that the FDA and other regulatory agencies have come to expect from industry is critical. The course will include a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product.
Who Should Attend
Purchasing, Materials Management, Development, Quality, Manufacturing, Engineering and Top Management
Industry: Pharmaceutical, Biotechnology, Medical Device
Learning Objectives
Attendees will learn how to:
• Understand requirements from regulatory agencies and other standards in relation to the suppliers and vendors approvals and qualifications, including procedure and documentation needs
• Be able to develop procedure and adequate documentation controls for the selection, approval and qualification (certification) and routine monitoring of vendors and suppliers. This includes the development of an audit program designed with different levels of formality depending on the criticality (risk based) of the material/component/service being provided
• Understand that controls are not limited to materials and components but also apply to contract service providers such as calibrations, laboratories, maintenance, contract manufacturing/packaging and others
This webinar will identify the following challenges/issues and discuss solutions being offered.
Challenge is to comply with our GMP requirements by controlling outsourced activities and materials but to implement adequate levels of control based on the risk/impact from those services/materials in the quality of our products.
Presenter
Miguel Montalvo
Expert Validation Consulting, Inc.
Miguel Montalvo, B.S. Chem. Eng., MBA, has over twenty-seven years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology and medical device industries including extensive expertise on development and implementation of quality functional procedures (QA/QC), Quality Systems, GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations, Change Control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.
Before starting EVC, Mr. Montalvo held senior level positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations in companies such as AAC Consulting Group, Inc, Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. His experience includes roles in the manufacturing side but also from the supplier point of view as QA Manager for the Custom Systems Division of Millipore Corp.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics for organizations such as IVT, PDA-TRI, CfPIE and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications and have been published as an author of specific chapters in several design/quality/validation related internationally-recognized reference books. He is a previous member of the Journal of Validation Technology editorial board and a current member for the last five years of the PDA Annual Program Committee for their Annual meetings.
Registration Fee
Individual: $225
Group:
2 people: $180.00 each
3 people: $150.00 each
4 people: $120.00 each
5-10 people: $100.00 each
11-15 people: $70.00 each
16-20 people: $60.00 each
21+ people: Call for pricing
Register by December 31 and receive 30% discount off above prices.
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