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FDA Inspections Symposium Costa Rica


CourseDirector Hosted by: Jackelyn Rodriguez

Ubicacion1 San Jose-Costa Rica

Date 15 - 17 May, 2019

logo MQSS

 

Ubicacion1
Doubletree by Hilton Cariari San Jose-Costa Rica
San Antonio de Belén, Ciudad Cariari 
www.CariariSanJose.DoubleTree.com
Mariposa

CourseCost
Pre-conference workshop
: $349.00
Symposium: $849.00
Combined: Pre-conference workshop  and Symposium:  $1,100.00


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CourseCost PAY AND REGISTER HERE CourseCost

Early bird discount:

Pre-workshop:
Early bird discount: $50.00 group discount (3 or more) for signing up by April 24, 2019

Symposium Only:
Early bird discount: $100.00 group discount (3 or more) for signing up by April 24, 2019

Combined Pre-conference workshop and Symposium:
$200.00 group discount (3 or more) for signing up by April 24, 2019

Group Discount: 3 paid registrations gets 4th registrations for free


 

Pre-conference workshop: $349.00
PAY AND REGISTER

Symposium: $849.00
PAY AND REGISTER

Combined: Pre-conference workshop  and Symposium:  $1,100.00
PAY AND REGISTER


AGENDA

PRE-CONFERENCE WORKSHOPS

Date Wednesday, May 15, 2019

Preconference Workshop: FDA Inspection Handling and Response to 483s and warning letters

Presenters: Jackelyn Rodriguez, RS, Founder, Monarch Quality Systems Solutions, LLC and Lisa Lopez, FDA

Part I:
12:30 p.m. – 5:30 pm        

Pre-Conference and Symposium Description:

Flawless FDA Inspection handling and response to FDA warning letters begin with a summary of the failed inspection, and often companies do not address the inspectional observations appropriately. As a result, the FDA categorizes one company after another as “inadequate,” “insufficient,” and often lacking information to support the organization’s response.
Handling an inspection requires a successful strategy designed to get the FDA investigator in and out as quickly as possible. It is critical to show that the organization is in a “state of control” in order to avoid an FDA 483.
Regulatory trends can be useful for planning and focusing on improvement projects and quality activities. In these sessions, participants will have the opportunity to review inspection data trends, to learn the most common problems identified in FDA 483 observations, and Warning letters, and most importantly, how to address issues as they arise, s well as the latest inspection trends.
The symposium will provide real examples to help you understand the context of these trends. Participants will hear from FDA the latest hot triggers and can have the opportunity to ask questions to FDA experts and learn more about FDA’s current regulatory landscape.
Attendees Will Learn:
This workshop is a practical, hands-on format, designed to provide the medical device, pharmaceutical, biopharmaceutical, and biologic professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.
•    Critical inspection preparation techniques
•    How to manage the inspection process
•    How to adequately prepare and test your Subject Matter Experts (SMEs)
•    How FDA investigators use the information to test your controls
•    How to speed the inspection to minimize the risk of 483 findings
•    Critical elements of a realistic regulatory inspection handling SOPs
Part II:
How to Effectively Management of Front and Back Inspection Rooms
What to prepare first?  Learn practical ways to identify risk areas and development of the right teams. How to qualify the right SME to present to FDA investigators.  How do you identify who has in-depth knowledge of your devices, processes, “How to identify high-risk areas” During this presentation, Ms. Rodriguez will provide you great tips to designing, staffing and managing your inspectional war rooms.
•    Understanding the collaboration of the front and back rooms;
•    Who should be in the front;
•    How to deal with ALL requests effectively in the back;
•    What happens if you discover bad or wrong records;
•    Tips for managing and staffing your war rooms with the appropriate people to interact with the FDA
Part III
Responding to Warning Letters and 483s
Sound responses to FDA findings are critical to a company's success in regaining a favorable compliance profile. Responses must incorporate well-designed and well-written corrective action plans that will convey a commitment for effective and sustained compliance.  This session will help attendees develop best practices for what they must do after they receive a 483 or Warning Letter.
Attendees will learn:
•    How to write an inspection response designed to reduce warning letter likelihood
•    Red flags FDA looks for in your inspection response
•    Common industry mistakes (approaches to avoid)
•    How to manage Form 483s and warning letters
•    Guidance for developing the written response
•    Defining Corrective and Preventive Actions (CAPA)
•    Key steps for effectively responding to FDA

 Attendees Will Receive:

Attendees will also get several extremely useful bonus materials than can be used to better prepare for the next inspection. Such as:

  • Sample SOPs, Inspection handling and response checklists , and other documents – ready for your immediate implementation.

CourseCost PAY AND REGISTER HERE CourseCost

Early bird discount:

Pre-workshop:
Early bird discount: $50.00 group discount (3 or more) for signing up by April 24, 2019

Symposium Only:
Early bird discount: $100.00 group discount (3 or more) for signing up by April 24, 2019

Combined Pre-conference workshop and Symposium:
$200.00 group discount (3 or more) for signing up by April 24, 2019

Group Discount: 3 paid registrations gets 4th registrations for free


 

Pre-conference workshop: $349.00
PAY AND REGISTER

Symposium: $849.00
PAY AND REGISTER

Combined: Pre-conference workshop  and Symposium:  $1,100.00
PAY AND REGISTER


Symposium Topics:

Date Day 1  – May 16, 2019

7:30 a.m. – 8:00 a.m.
Registration and Continental Breakfast 

8:00 a.m. – 8:15 a.m.
Opening Comments by Chairperson Jackelyn Rodriguez, Founder, Monarch Quality Systems Solutions, LLC  

8:15 a.m. – 9:15 a.m.
FDA Inspection Trends: a review of 483s and Warning letters

Presenter: Lisa Lopez, FDA

Regulatory trends can be useful for planning and focusing on improvement projects and quality activities. In this session, participants will have the opportunity to review inspection data trends, to learn the most common problems identified in FDA 483 observations, and Warning letters. This session will also provide real examples to understand the context of these trends. Participants will have the opportunity to ask questions to an FDA expert and learn more about the FDA’s Office of Regulatory Affairs and the current regulatory landscape.

9:15 a.m. to 10:00 am An Overview of the Latest Recalls:  What failed? Quality Systems or Risk Management

Presenter: Captain Joseph L. Salyer, RS, MPH US Public Health Service (Retired)

Periodically there are failures that result in recalls. Recent recalls will be reviewed and the failure, as well as what may have prevented the failure. A structured Hazard Analysis and Critical Control Point (HACCP) risk management program will identify the possible processor device failures, predetermined corrective actions, and identify necessary actions in case of an unanticipated failure. Potential failures and potential patient injuries can be linked to the HACCP risk management process to help assure the necessary actions are taken in a timely manner. Quality systems will be in the background for this session.

10:00 a.m. - 11:00 a.m. Preparing for the MDSAP Audit Process: A are you ready?

Presenter: Dennis Moore Director RAQA at Hudson Scientific Ex-FDA Investigator, California Medical Device Senior Investigator

One big advantage to the MDSAP is that because audits aren’t performed by the U.S. government, their results aren’t public record — and there’s no Form 483 that can be requested via the Freedom of Information Act.

In this session, the attendee will receive a detailed checklist for your MDSAP audit. I will cover how to prepare for the inspection, what areas to clean up and insight on how to answer the inspector’s probes. I will cover the unique audit finding scaling system, and I will also have a full MDSAP report as a handout. The final report will be examined for content during the training session

Manufacturers entering the Medical Device Single Audit Program undergo an assessment performed by a single third-party inspector that proves compliance in the US, Canada, Australia, Brazil, the EU, and Japan. The audit process is not what you’re used to comparing to an FDA or ISO audit.

Mr. Moore will take you through the preparation process from the manufacturing perspective. You will also hear what lessons they learned along the way, what they would have done differently and how it compares to a corporate audit versus a small manufacturing plant audit.

This presentation will cover:

  • What to do to prepare for the audit
  • The audit flow and how it differs from QSIT and ISO audits
  • Bonus: Attendants will receive a copy of the MDSAP Audit checklist

11:00 a.m. – 11:15 a.m. Refreshment Break

11:15 a.m. – 12:30 p.m.
FDA’s Documentation requests: are you ready?

Timothy Couzins, Ex- FDA Compliance Safety Officer/Investigator.

Responsible for formulating necessary legal sanctions against violators of the Food, Drug, and Cosmetics Act, as amended, and related statutes.

  • As an expert in the District for matters relative to medical devices, held hearings and developed the District’s recommendations for disposition of cases, including the most complex cases.
  • Made administrative review of laboratory records and inspectional reports reflecting violative conditions. Assessed the evidence, conferred with responsible program officials to determine the need for additional evidence including CDRH personnel and the Office of Chief Counsel. Evaluated all available evidence, determined the nature of the violation, and initiated appropriate regulatory action.
  • Participated in the training of new investigators in the legal aspects and laws of evidence connected with the Agency’s programs. Mr. Couzins has been working as an independent consultant for several Pharmaceutical, Biologics and Medical Device Companies all over the world.

During an inspection, FDA investigators can ask for anything. It is becoming more and quite common for investigators to review your documents and data maintained in your QMS in real time. An investigator may request electronic copies of your records on a memory stick. How do you select the proper types of spreadsheet for complaints, CAPAs, etc. Can the investigator request to browse through your complaint management system or other systems to review documentation? How can you prepare?

  •  What is FDA's new ability to analyze your data
  • How should the organization sort it and recognize trends which they can then link to potential issues in other quality management systems. Some documents don’t stand on their own without significant explanation.
  • · Learn how the importance of writing plain, simple English — How all documents need to show what you need without additional interpretation.

Bonus: Attendants will receive a copy of the Data Integrity Audit checklist

12:30 p.m. – 1:30 p.m. Lunch Break

1:30 p.m. – 2:15 p.m
How to prepare for an FDA Inspection & Role play exercises

Prepared by: Elaine Messa, RAC, FRAPS, Founder & Principal at Messa Consulting Group LLC, former Director of the Los Angeles District, FDA, Presented by Jackelyn Rodriguez

From a business and compliance perspective, it is critical for a successful inspection outcome that a manufacturer understands the relevant regulatory requirements and how FDA Investigators prepare for and conduct the inspection. The company should proactively engage with the Investigators for a balanced view of complaints, Corrective and Preventive Actions (CAPAs), and other observations identified by the Investigators. Lastly, it is important to ensure that the company’s interactions with the Investigators during the inspection and communication following the inspection successfully address the appropriate audience to resolve issues and avoid further enforcement action.

This presentation will ensure a general understanding of the following:

  • FDA’s responsibilities for conducting inspections in accordance with the law (Federal Food, Drug, and Cosmetic Act)
  • What records and documents companies are required to provide to FDA and which documents may they may refuse FDA access to
  • Inspection guides used by FDA Investigators
  • How to develop an inspection Standard Operating Procedure (SOP) that includes critical topics such as photography, affidavits, and electronic data requests and how to respond to these requests
  • The “Top-down vs. Bottom-up” approach that FDA Investigators use to collect and document evidence.
  • How to successfully communicate with the FDA following the inspection

Interactive Group Exercise: Review of inspection case study

2:15 p.m. – 3:00 p.m.
Using the Six Sigma program to Minimize wasteful processes:

Omar Mora, Business Development Manager at Blackberry&Cross

Lean Six Sigma certification training is devised to incorporate the concepts of Lean (reduce waste) and Six Sigma (reduce variation). The concepts of these methodologies complement each other and produce a synergistic impact in achieving profound results.

Measuring Waste. Lean Six Sigma aims to help reduce and minimize your production waste by measuring each individual process. Although this may be time-consuming compared to other methods, this is the most effective way to reduce your overall waste. First, you must decide which processes you want to measure.

  • Learn how to determine proper statistical techniques
  • Ho to the most effective way to reduce your overall waste while maintaining compliant processes
  • Where to implement Lean Six Sigma

3:00 p.m. – 3:15 p.m. Refreshment Break

3:15 pm. - 4:00 p.m.
FDA’s expectations for Change Control (change verification vs.
validation)

Presenter: Dennis Moore Director RAQA at Hudson Scientific Ex-FDA Investigator, California Medical Device Senior Investigator

During this session, we will examine actual change logs, and explore best FDA practices when a process changes or material change occurs. We will dive into 510k issues when a change occurs (what FDA expects when you perform a change). I will hand out an effective change control SOP and ECR that will help bring home the points regarding FDA expectations. QSIT implications will also be discussed.

  • Learn what changes require Validation vs. verification
  • How to classify changes to determine needed validations
  • How much validation is enough to show that changes are effective?
  • Change controls related to suppliers
  • Bonus: Attendees will receive a copy of a robust change control SOP

4:00 p.m. – 4:45 p.m.
The Dreaded Inspection: How an Effective Hazard Analysis and Critical Control Point (HACCP) Program Prepares a Facility and Expedites the Process

Presenter: Captain Joseph L. Salyer, RS, MPH US Public Health Service (Retired)

The inspection or auditing process is often a very stressful and tense time for a facility. An effective and properly implemented HACCP risk management program helps to assure that everything is in place for inspection. The structure guides the process so that the auditor can be provided with documentation in a timely manner and cover the necessary elements of the QSIT or ISO inspection, including new processes or component changes, process failures, corrective actions, recalls, etc. In fact, HACCP is the required inspectional tool in many establishments. This session will show how to structure your program for a more pleasant inspection using HACCP.

4:45 p.m. – 5:30 p.m.
Panel Discussion: How to Deal with Difficult Inspections

Co-Chair Captain Joseph L. Salyer, RS, MPH US Public Health Service (Retired), and long-time industry expert, Co-Chair Jackelyn Rodriguez , will provide real-world scenarios for dealing with tense inspections. Through open discussion and feedback, the audience will work together to come to the correct conclusion for each scenario.  Our experts will also answer those questions that have been distressing organizations for years. Don’t miss this exciting panel!


CourseCost PAY AND REGISTER HERE CourseCost

Early bird discount:

Pre-workshop:
Early bird discount: $50.00 group discount (3 or more) for signing up by April 24, 2019

Symposium Only:
Early bird discount: $100.00 group discount (3 or more) for signing up by April 24, 2019

Combined Pre-conference workshop and Symposium:
$200.00 group discount (3 or more) for signing up by April 24, 2019

Group Discount: 3 paid registrations gets 4th registrations for free


 

Pre-conference workshop: $349.00
PAY AND REGISTER

Symposium: $849.00
PAY AND REGISTER

Combined: Pre-conference workshop  and Symposium:  $1,100.00
PAY AND REGISTER


Ubicacion1 Day 2  – May 17, 2019

8:00 a.m. – 9:00 a.m.
Robust Complaint Handling and Investigations

Presented by: Lisa Lopez, FDA

Is it possible for a comment on social media to be considered a complaint? Do you know the difference between servicing and complaints? When are complaints related to malfunctions reportable?

During this session, participants will get the answer to these questions and much more from an FDA and Quality Management expert. Participants will understand the requirements for reviewing, evaluating, and investigating complaints. Reporting and Record requirements will be also covered.  This session will also cover best practices that may help avoid common pitfalls by reviewing real examples.

Topics:

  • Definitions
  • Basic Requirements
  • Reviews and evaluations
  • Risk-based investigations
  • The link between Complaints and CAPA
  • Reporting Requirements
  • Record Requirements
  • Common Problems (and how to avoid them)

9:00 a.m. – 09:45 a.m.
Effective Internal Audits: Improvement based on critical findings

Presenter: Dennis Moore Director RAQA at Hudson Scientific Ex-FDA Investigator, California Medical Device Senior Investigator

A company’s Internal Audit Team can be your best line of defense for Quality Results that can be used to focus on critical issues.  Understating the organization pitfall thru the internal audit of your quality management system should be a collaboration, not a confrontation, with auditor and auditee working together to spot issues that weaken your system. Your internal audits can be a positive and productive experience for all if you apply the lessons in this session:

  • How to identify Critical issues vs. minor issues;
  • How to Select the right team to address critical issues;
  • How to train your employees to handle audits in the most productive way;
  • How to select the best auditor to work with your team;
  • How to follow the internal audit with corrective action;
  • How to report audit findings to management and get them to buy into suggested solutions; and ƒ How to evaluate your internal auditing system’s effectiveness.

09:45 am -10:30 a.m.
Effective Risk Management: How to Implement a Hazard Analysis and Critical Control Point (HACCP) Program as the basis for a Risk Management Plan

Presenter: Captain Joseph L. Salyer, RS, MPH US Public Health Service (Retired)

Risk management has been the buzz word for several years in medical device manufacturing. However, there are many risk management tools that are used. HACCP is a tool that can be used as the basis for a complete program. Failure Mode Effects Analysis (FMEA) will briefly be discussed, since it is a commonly used tool, and compared to HACCP. In this session, HACCP will be introduced and demonstrated to show its universal adaptability for a risk management system to meet the Quality System Regulation, as well as how to integrate other tools and regulatory requirements.

10:30 a.m. - 10:45 a.m. Refreshments break

10:45 a.m. - 12:30 p.m.
ISO 13485:2016 – Understand the Concepts of Risk and Their Applications The new QMS standard: Are you prepared?

Presenter: Lisa Lopez, FDA

Ms. Lopez is a results-oriented strategic leader with more than 25 years of regulatory/quality experience. She started her FDA career as an investigator, inspecting the medical device, food and pharmaceutical firms and became a Level 2 Medical Device Investigator. She has served in multiple roles within FDA such as Supervisory Investigator, Import Program Manager, Pre-approval Manager, Director of Investigators, Assistant Director and Deputy Regional Director of the Latin America Regional Office, Quality Program Manager, Supervisory Quality Manager, and Deputy QMS Director. She has been recognized through several awards including the FDA Pioneer Award and the Quality Manager of the Year.  Prior to joining FDA, Ms. Lopez held positions in Quality and Regulatory Affairs in the pharmaceutical, cosmetics, food and medical device industries.

ISO 13485:2016 – Understand the Concepts of Risk and Their Applications The new QMS standard, published in March, alerts manufacturers to the presence of risk in almost all operations—from audits, design control, software validation, supplier management to and more. While it does not specifically address the concept of risk management (you’ll find that in ISO 14971:2007), ISO 13485:2016 makes it quite clear that manufacturers must be aware of the opportunity for risk in all they do.

This presentation examines the concept of risk as presented in the new standard and explains how to apply it in the quality management systems. Through examples that illustrate ISO 13485:2016’s requirements, interactive exercises that help solidify understanding, and a unique set of checklists that cover all the QMS bases.

 Learn how the QMS standard integrates with the risk management standard in ISO 14971:2007 · How the implementation timeline may differ from country to country Quality systems expert Lisa Lopez will explain ISO 13485:2016’s concept of risk and how to prepare companies for the new changes.

1:30 p.m. - 2:30 p.m.
Building Effective Data Integrity Programs

Timothy Couzins, Ex- FDA Compliance Safety Officer/Investigator.

Responsible for formulating necessary legal sanctions against violators of the Food, Drug, and Cosmetics Act, as amended, and related statutes.

  • As an expert in the District for matters relative to medical devices, held hearings and developed the District’s recommendations for disposition of cases, including the most complex cases.
  • Made administrative review of laboratory records and inspectional reports reflecting violative conditions. Assessed the evidence, conferred with responsible program officials to determine the need for additional evidence including CDRH personnel and the Office of Chief Counsel. Evaluated all available evidence, determined the nature of the violation, and initiated appropriate regulatory action. 
  •  Participated in the training of new investigators in the legal aspects and laws of evidence connected with the Agency’s programs. Mr. Couzins has been working as an independent consultant for several Pharmaceutical, Biologics and Medical Device Companies all over the world.

Co-Presenter: Presenter: Jackelyn Rodriguez, RS, Founder, Monarch Quality Systems Solutions.

Ms. Rodriguez has over 35 years of extensive experience working in the Medical Device, Pharmaceutical, Biologics, Compound Pharmacy, Clinical Studies, Pharmacovigilance, OTC, OTC Cosmetics industries. She has worked both within the industry and as a Principal Consultant to the industry. For over 21 years she held multiple positions as Director of Quality and Regulatory Compliance, and Senior Manager of Quality and Regulatory Affairs. In addition, she has more than 17 years as an independent consultant advising to industry leaders. Ms. Rodriguez also has extensive knowledge of Compliance- Mock Inspections, Facilitating responses to address FDA-483s and Warning Letters, and she has helped many companies (worldwide) to prepare for FDA inspections and participated/facilitated responses during the inspection (in front room) and managed back room as well.

Quality-Driven Data Integrity Approach In the EU and US Inspections Data integrity requirements have been strongly enforced in recent years by almost every regulated agency in the pharmaceutical environment: the expectations have been clarified in a number of guidance issued by MHRA, WHO and most recently by the FDA. Therefore, the requirements for data integrity are now considered a fundamental expectation and strictly connected to the relevant predicate rules. This presentation will provide real-life case studies and examples you can use to base your control measures upon the potential impact of data on product quality and patient safety.
The session will examine the structural contributors to achieving positive, consistent data integrity outcomes. It will examine important requirements inputs to developing data integrity systems and will examine specific control frameworks, systems, monitoring and detection programs to ensure continued achievement of compliant, valid, data and information chronicling, recording and reporting. Questions to be answered include:

1. When is it permissible to exclude CGMP data from decision making?
2. Does each workflow on our computer system need to be validated?
3. How should access to CGMP computer systems be restricted?
4. Why is FDA concerned with the use of shared login accounts for computer systems?
5. How should blank forms be controlled?
6. How often should audit trails be reviewed?
7. Who should review audit trails?
8. Can electronic copies be used as accurate reproductions of paper or electronic records?
9. Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments?
10. Can electronic signatures be used instead of handwritten signatures for master production and control records?
11. When does electronic data become a CGMP record?
12. Why has the FDA cited the use of actual samples during “system suitability” or test, prep, or equilibration runs in warning letters?
13. Can an internal tip regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system?
14. Should personnel be trained in detecting data integrity issues as part of a routine CGMP training program?
15. Is the FDA investigator allowed to look at my electronic records?
16. How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed?

Bonus: Attendants will receive a copy of the Data Integrity Audit checklist

2:30 p.m. – 3:15 p.m.
Responding to Warning Letters and 483s

 Presenter: Jackelyn Rodriguez, RS, Founder, Monarch Quality Systems Solutions, LLC

Credible responses to FDA findings are critical to a company's success in regaining a positive compliance profile. Responses must incorporate well-designed and well-written corrective action plans that will convey a commitment for effective and sustained compliance.  This session will help attendees develop best practices for what they must do after they receive a 483 and/or Warning Letter.

Attendees will learn:

  • Common industry mistakes (approaches to avoid)
  • How to manage Form 483s and warning letters
  • How to prioritize findings to develop a robust response
  • Defining Corrective and Preventive Actions (CAPA) plans
  • What objective evidence should be attached to the response

3:15 p.m. – 3:30 p.m. Lunch Break

3:30 p.m. – 4:15 p.m.
Effective Internal Audits: Improvement based on critical findings

Presenter: Dennis Moore Director RAQA at Hudson Scientific Ex-FDA Investigator, California Medical Device Senior Investigator

During this session, we will take real-life audit findings and examine CAPA approaches to effect permanent change and improvement. We will also look at poor CAPA approaches, and discuss strategies for effectiveness verification. We will discuss how to shield IA findings from FDA investigators when they enter the CAPA system

An internal audit of your quality management system should be an effective tool.  Your internal audits can be a positive and productive experience for all if you apply the lessons in this session:

  • How to evaluate your internal auditing system’s effectiveness;
  • Learn how to train your employees to handle audits in the most productive way;
  • How to select the best auditor to work with your team;
  • How to follow the internal audit with corrective action;
  • How to evaluate your internal auditing system’s effectiveness.
  • How to close audit observations.

4:15 p.m. - 4.45 p.m

FDA and ISO 13485:2016 Requirements For Computer System Validation: How to effectively meet the requirements

Presenter: Jackelyn Rodriguez, RS, Founder, Monarch Quality Systems Solutions.

Ms. Rodriguez has over 35 years of extensive experience working in the Medical Device, Pharmaceutical, Biologics, Compound Pharmacy, Clinical Studies, Pharmacovigilance, OTC, OTC Cosmetics industries. She has worked both within the industry and as a Principal Consultant to the industry. For over 21 years she held multiple positions as Director of Quality and Regulatory Compliance, and Senior Manager of Quality and Regulatory Affairs. In addition, she has more than 17 years as an independent consultant advising to industry leaders. Ms. Rodriguez also has extensive knowledge of Compliance- Mock Inspections, Facilitating responses to address FDA-483s and Warning Letters, and she has helped many companies (worldwide) to prepare for FDA inspections and participated/facilitated responses during the inspection (in front room) and managed back room as well.


Manufacturers who continue to see increased enforcement of these regulations include Device and pharmaceutical companies, still faced many challenges as to how to determine the level of validation needed to ensure robust software validations and Par 11 compliance. For small to mid-sized manufacturing companies, software validations needed can seem like an overwhelming task. However, the benefits of validating prove to be well worth the cost.This presentation will review the FDA and ISO requirements for computer system validation and describe methods for meeting those requirements. Emphasis is placed on applications currently used in production and quality systems, such as document control, ERP, complaint, and QA systems, and manufacturing execution systems. Attendees will gain the tools needed to ensure compliance for both Software validation as well as Part 11 programs.What Attendees will Learn:

  • What must be validated to meet FDA and ISO 13485 requirements
  • The top errors in computer system validation
  • What procedures are required and where to get them
  • How to prioritize software needing validation
  • What approaches that are commonly used: prospective, concurrent, and retrospective
  • How to validate existing systems using a combination of concurrent and retrospective validation

Bonus: Software Validation SOP

4:45 p.m. - 5:15 p.m. Panel Questions and Answers- Ask Anything!

5:15 p.m. Symposium  Adjourn

Registration Policies and Procedures.

Cancellations and Refunds: Written cancellations received by 5:00 pm ET on 30 days prior to any MQSS event will be refunded within 30 days of payment in full minus a $100 administrative fee. MQSS Refunds will not be granted after the event begins for failure to attend, late arrivals, early departures, changes to the agenda or speaker roster or balance due to registrations received after the registration deadline. MQSS does not accept phone cancellations. Please call +1-609-744-4559

Substitutions: No substitutions are allowed.
Meeting Cancellation: MQSS reserves the right to cancel any conference at its sole discretion, whereupon all registration fees will be refunded. MQSS is not responsible for any costs incurred due to a cancellation.
Agenda/Speakers: Subject to change without notice.


CourseCost PAY AND REGISTER HERE CourseCost

Early bird discount:

Pre-workshop:
Early bird discount: $50.00 group discount (3 or more) for signing up by April 24, 2019

Symposium Only:
Early bird discount: $100.00 group discount (3 or more) for signing up by April 24, 2019

Combined Pre-conference workshop and Symposium:
$200.00 group discount (3 or more) for signing up by April 24, 2019

Group Discount: 3 paid registrations gets 4th registrations for free


 

Pre-conference workshop: $349.00
PAY AND REGISTER

Symposium: $849.00
PAY AND REGISTER

Combined: Pre-conference workshop  and Symposium:  $1,100.00
PAY AND REGISTER


logo MQSS
P.O. Box 68 Marlton , New Jersey 08053
Office: +1- 856-8103780
Cel. +1-609- 744-4559
Fax: 856-596- 0155
Email: info@monarchquality .com


 

Understanding the level of expertise, service, and products your company brings to the industry, we would like to present a sponsorship opportunity to you at our upcoming conference. There are limited opportunities and we would like to invite your company to become a Gold or Silver Sponsor.

 These 2 packages include:

A Gold Sponsor will receive:

  • Two total registrations for your company for the 2-day Symposium
  • 6′ Tabletop display
  • Logo on event signage
  • Advertisement and marketing presence – print and online
  • Enhanced company listing and logo in onsite program

Price: $1,895   REGISTER AND SPONSOR

A Silver (Supporting Company) will receive:

  • One registration for your company for the 2-day Symposium
  • 6′ Tabletop display
  • Advertisement and marketing presence – print and online

Price: $1,495   REGISTER AND SPONSOR

*Before registering for any of our courses, read our Cancellation policy and  registration policies and procedures.
*All courses can be taught in Spanish