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Parenteral Drug Association Connecting People, Science and Regulation ®

Application of a Quality Systems Approach to Pharmaceutical CGMPs

Jun 26 - Jun 27, 2018 |
Jun 27, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This course will 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. It will also describe the requirements in the ICH Q10 guideline and how it compares to the FDA document.

The course will include discussions on each quality system element 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 applied during the implementation. An effective plan for compliance can be developed and executed when addressing these specific requirements: CAPA, internal audits, outsourcing management, risk management, data integrity and change control. You will learn how to conduct a Gap Analysis to determine your level of compliance and the recommendations for implementation of remedial and permanent actions to address any gaps found. The objective of the course is to describe the requirements of the Quality Management approach to drug GMPs and the strategy for a risk-based implementation.

Who Should Attend

Attendance will be beneficial to personnel directly involved in quality systems activities and procedures including quality control/laboratory operations and quality assurance, validation, process/product development and manufacturing operations. Individuals in management who interact with the above or with regulatory agency inspectors to rationalize or defend their quality systems policies and procedures will also benefit from attending this course.


Personnel attending the course should be familiar with CGMP regulations and have a minimum of three years of experience in the pharmaceutical manufacturing environment. No certification or additional requirements are necessary.

Upon completion of this course, you will be able to:

  • Explain the specific requirements of the elements within the quality systems and which areas require more attention based on the overall product quality impact
  • Identify which elements will require a cultural change and overall management commitment for its implementation
  • Conduct a gap analysis to determine your level of compliance and be able to prioritize recommendations based on the more critical gaps
  • Implement these quality systems using a science/risk-based approach
  • Apply different levels of CAPA, internal audits and supplier audits corresponding to the risk being addressed



On or before May 11, 2018

After May 11, 2018


On or before May 11, 2018

After May 11, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by May 28, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Miguel Montalvo, President, 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.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #265 | ACPE #0116-0000-17-037-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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