Speaker Profile

Miguel Montalvo

President, Expert Validation Consulting, Inc.

Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight 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.

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 member of the Journal of Validation Technology editorial board and of the PDA Annual Program Committee for their Annual meetings.




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Change Control Management – From Design to Commercialization

There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems.

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Outsourcing Management - Effective Contract Manufacturers, Supplier Evaluation, Approval and Monitoring

Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. 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.

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Effective Application of CAPA using a Risk-Based Approach

It is imperative to apply CAPA at a level commensurate with the risk to the product quality resulting from the failure being addressed. A formal CAPA process must not be applied without a risk assessment of the event/system failure and the level of detail/depth during the investigation must correlate with the risk level to the product quality also considering the probability of re-occurrence and the detection capabilities if the event or failure should occur again. This session will address how to apply different levels of the CAPA process corresponding to the risk being addressed.

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