Makromed Costa Rica, in association with MyFDAAcademy.com
- Earn a certificate as you complete each course.
- Get certified as a PV SME when you complete all courses.
Presented by the Makromed team that has extensive experience and international reputation in offering QMS consulting services and QMS software to address the compliance requirements of: U.S. FDA’s GMP / QSR, EU’s MDD / MDR, ISO 13485, and other global regulations and standards.
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Learn about Makromed Inc and its experience
Makromed, Inc. is an ISO 13485 certified U.S. based company that has 8 years of presence in Costa Rica
and 30 years internationally.
We are staffed with highly qualified professionals in various disciplines, focused on the Pharmaceutical and Medical Devices industry, both in Costa Rica and worldwide.
Solutions we provide
We are known for providing innovative software and consulting solutions for quality and regulatory compliance to the medical devices, pharmaceutical, neutraceutical and biotechnological industries worldwide.
Meet our professional
SPEAKERS
Barry Ashar
Barry Ashar has over three decades of experience working with medical device and biotechnology companies on projects ranging from new product development to postmarket audits.
Barry is the founder and president of Makromed, a technology‐based company that provides technical products and services to the medical device, diagnostics, pharmaceutical and biotechnology industries in the fields of RA/QA and Engineering. Clients regularly leverage his expertise in commercialization, design controls, software validation, data integrity and security, engineering documentation, regulatory submissions, and quality and regulatory compliance & auditing.
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A Certified Lead Auditor, Barry has audited against U.S. Food and Drug Administration (“FDA”) Good Manufacturing Practices (“GMP”), FDA Quality System Regulations (“QSR”), FDA Part 11 (Electronic Records and Electronic Signatures), EU Medical Devices Directive, The Health Insurance Portability and Accountability Act (“HIPAA”) and International Organization for Standardization (“ISO”) 13485, 14971 and 62304 regulations and standards. Barry has conducted technical, quality and regulatory due diligence audits for investors and M&A clients.
Barry’s experiences include preparing and submitting 510(k) and PMA applications on software‐driven medical devices and procuring FDA’s clearance, conducting certification audits at companies in receipt of FDA Warning Letters, training staff on design controls and software validation, implementing automated quality system tools, and supervising senior technical staff and managers in R&D, engineering, regulatory, and quality groups. Barry has been an invited speaker and instructor at various domestic and international conferences on medical devices, and has published numerous technical and business articles in trade journals and technical books.
Holder of Master of Science degrees from Northeastern University and the University of Massachusetts, Barry is a member of the American Association for the Advancement of Medical Instrumentation, American Management Association, and Regulatory Affairs Professionals Society.
Christian Castro
Christian Castro has over 9 years of professional experience working with medical device industry.
Christian’s experiences include project management of engineering, manufacturing and QS projects, process validation and equipment qualification, IQ, OQ and PQ protocols writing and executions, Subject Matter Expert (SME) on CNC operations and validations, Process controls, statistical analysis and design of experiments, CAPA investigations and root cause analysis, Risk management and FMEAs.
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Trained auditor for quality systems. Technical and QA consulting on process validation, equipment qualification and statistical analysis. Software validation testing for quality system software and equipment software. Providing training on process validation. Project Manager at client sites for FDA Remediation-related process validation projects. Prepared interactive courses on various QS topics for MyFDAAcademy.com online training site.
He is QS/Regulatory Associate and QS Engineering Manager for Makromed Inc. Costa Rica and holds a Bachelor’s degree in Industrial Engineering, trained on Project Management Tools, industrial statistics, dimensional metrology, CNC machines operation and programming, engineering drawings and audits of quality systems.
Get Certified in Process Validation
Let us be part of your solution
Implementing our know-how and best practices developed over the years.
View the available
COURSES
Process Validation Overview
October 31, 2019
8 am – Noon – $100
- PV Policies
- PV Regulations
- Emphasis on Validations vs. Verifications
- Risk-based Approach to Validations
- PV Architecture
- Master Validation Plan (MVP) for Product Families
- PPQ Approach to Product Families
- Process Monitoring
- Equivalency Guidelines
- Revalidation Guidelines
- PV Metrics
- Validation Review Board (VRB)
Sampling Plans for PV and TMV
November 29, 2019
$150
- Review of important statistical terms and concepts
- Variable vs. Attribute Data
- Sampling Plan Protection: AQL and LTPD
- Operating Characteristic (OC) Curve of a Sampling Plan
- Performance Standard: Confidence and Reliability
- Alpha and Beta Errors
- Risk-based Approach to Sampling Plans
- Sampling Plans for Process Validation (PV)
- Plans for OQ vs. PQ/PPQ
- Sampling Plans for Attribute Test Method Validations (ATMV)
- Sampling Plans for Variable Test Method Validations (VTMV)
Equipment Qualification (EQ/IQ)
January 22, 2020
$150
- Regulation and standards
- EQ vs IQ
- Equipment classification
- Intended use
- Base risk for equipment
- Equipment lifecycle
- EQ/IQ Form (Initiation, Planning, Requirements/Specs, IQ and Closing)
- Keeping the validated state (PMIQ)
- Decommissioning
- EQ timing
Test Method Validation (TMV)
February 28, 2020
$150
- TMV Policies
- Test Methods for Verifications and Validations
- Primary vs. Secondary TMVs
- Attribute vs. Variable TMVs
- Relative Order and Timing of PV Elements
- Inputs and Outputs of TMV
- Principles of ATMV
- Intended use and base risk
- Alpha and Beta sampling plans
- Blind randomized study
- SME vs. Inspector results
- ATMV Form (Initiation, Planning, Execution and Closing)
- Principles of VTMV
- Analytical Performance Characteristics
- Performance Criteria for VTMVs
- Gage R&R and ICH Model
- Challenges with Destructive Tests
- VTMV Form (Initiation, Planning, Execution and Closing)
- Deviations and Failures
Operational and Performance Qualification (OQ/PQ)
March 25, 2020
$150
- OQ/PQ Policies
- OQ vs. PQ
- PQ vs. PPQ
- Product Requirements vs. Process Outputs
- Risk-based Sampling Plans
- Process Description and Intended Use
- Process Outputs – attribute and variable
- Process Inputs – outer limits, challenge scenarios, nominal conditions
- OQ Form (Initiation, Planning, Execution, Closing)
- Number of PQ Runs
- Manufacturing Variability
- PQ Form (Initiation, Planning, Execution, Closing)
- Deferring PQ testing to PPQ
- Deviations and Failures
Register Now
This is a unique opportunity to master advanced knowledge and get certified in Process Validation.
Please complete the form to request detailed information about the registration process.
More Information
Contact Marianela Alvarado, Business Coordinator Makromed. E-mail: malvarado@makromed.com
The Location
The courses will be taught in Centro de Capacitación, Coyol, Alajuela