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Application of a Quality Systems Approach to Pharmaceutical CGMPs

Jul 20 - Jul 21, 2020
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

This training course will help you define the concepts behind the application of the Quality Systems to drug operations and the specific elements as discussed in the FDA guideline: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities as well at the requirements in the ICH Q10 guideline and how it compares to the FDA document.

During this training course, you will learn about quality system elements from a risk-based approach so that the specific requirements can be prioritized based on the highest impact to product quality; this prioritization scheme can be then applied during implementation. Activities include developing and implementing an effective plan for compliance that addresses these specific requirements: CAPA, internal audits, outsourcing management, risk management, knowledge management and change control.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Assurance Training Courses

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Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Miguel Montalvo
Miguel Montalvo
Expert Validation Consulting, Inc.
Bio
Miguel Montalvo
Expert Validation Consulting, Inc.

Mr. Miguel Montalvo has over 34 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities. He is the owner and President of Expert Validation Consulting, Inc, a firm specialized on focused and practical consulting for the pharmaceutical, biologics, medical devices and OTC drug industries on cGMP compliance areas.

Before forming EVC, Mr. Montalvo held positions of increasing responsibility in the areas of Compliance Consulting, 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. He has developed and implemented comprehensive and compliant GMP, Quality Systems and validation programs/systems for numerous companies and provided support/audits/assessments for many existing operations. His extensive expertise areas include development and implementation of quality functional procedures (QA/QC) and quality systems, internal and external cGMP audits including remediation efforts for companies under a consent decree, handling of non-conformances including investigations and deviations, all areas of validation, change control, CAPA, international GMP guidance and compliance, Calibrations, Risk Management and start-up of manufacturing facilities.

He holds a BS in Chemical Engineering from Rensselaer Polytechnic Institute and an MBA. He has been a frequent speaker/chairman/instructor at hundreds of compliance, validation and quality related conferences and courses around the world for such groups as PDA, PTi, CfPIE, IVT, Barnett International and the CTFA, his articles/papers have been published in the PDA Letter, American Pharmaceutical Review and the Journal of Validation Technology publications, he has authored chapters in recognized industry reference books and the PDA book on “Effective Implementation of Audit Programs”. He has been a member of the IVT Journal of Validation Technology Editorial Board and the PDA Annual Meeting Planning Committee.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain the specific requirements of the elements within the quality systems and which areas require more attention based on the overall product quality impact
    2. Identify which elements will require a cultural change and overall management commitment for its implementation
    3. Conduct a gap analysis to determine your level of compliance and be able to prioritize recommendations based on the more critical gaps
    4. Apply different levels of CAPA, internal audits and supplier audits corresponding to the risk being addressed
  • Who Should Attend

    This training course is intended for professionals who are involved directly involved in quality systems activities and procedures.

    Departments
    Quality Assurance, Manufacturing, Validation, Quality Control

    Roles
    Specialist, Analyst, Supervisor, Manager

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By June 5, 2020
Member $1,889
Non-member $2,267
Gov't/Health Auth./Academic* $1,469



Regular Registration
Registration Type Price After June 5, 2020
Member $2,099
Non-member $2,519
Gov't/Health Auth./Academic* $1,469



* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10
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