2-day In-person Seminar

Quality System Regulations for Drugs, Devices, and Tablets and How to generate your DMF

By Jerry Dalfors

Coming soon.. Please contact customer care for new schedule
Group participations

Overview

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Course "Quality System Regulations for Drugs, Devices, and Tablets and How to generate your DMF" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:

Primary Student Objectives - General High Level Topics where we will move down to very specific discussion and details to generate a much higher comprehension for quality individuals even though during this course you will not have to take a final exam!

Upon completing this course participants will gain a much better Quality Systems comprehension, based on the instructor's decades of experience helping generate quality system regulations, working with the FDA, fixing FDA findings and generating a synergistic discussion with the attendees to help us all make sure we understand that there is rarely ever on "one" way to do things or "right and wrong", just like making an assumption about the Root Cause of an incident rather than working together to realize there are other things that took place that the individual making the assumption may not have been aware of.

1. What is expected from the QA professional and how other industries (FAA, ISO, EPA, etc.) have made Quality Systems so profitable by having the Head of Operations and the Head of Quality trading places every 6 months.

2. Gaining a more practical Comprehension from experience of the Quality Systems regulations not just reading and thinking you are an expert (reading three books on how to ride a bicycle does not make you an expert).

3. Once we have a better perspective then we will identify the necessary activities like working on a thesis to generate the needed performance for the entire Quality System.

4. How to apply current technology to generate the objective evidence needed to generate the attitude of making the FDA successful when inspecting by answering all the potential inspector questions before asked. Use the applicable technology to think like an FDA inspector

5. How are we going to maintain documented evidence to prove that the process and initial validation is still working in accordance with the Quality System regulations

6. Make sure we have the proper tools and comprehension to perform the needed internal audits which ensures that when a client audits the company or the FDA inspects the facility, we have already been doing all the things they might be reviewing.

7. Making sure that all the laboratory, inspection, calibration, and related quality verification activities are working in a way that generates higher profitability by generating continuous quality improvement (CQI)

8. Ensuring that vendors are practicing the similar quality performance to make sure we don't get hit by their lack of consistency and quality performance based on the needed specifications for our process or products.

9. Defining the expected although not actually defined by the FDA what we need to demonstrate GDP (good documentation practices) which also serve as "legal" documents if something negative happens.

10. Management of Incidents, Deviations, Changes - Incident tracking systems(ITS), deviation management (OOS, OOT, OOL, etc), Critical Change Control (CCR) and Corrections, Corrective Action and Preventative Action (CAPA).

11. Batch Production Record (BPR) or Device History Record (DHR) related to the master versions of the documents used for production and the review before release.

12. How to use statistics for Quality Systems and make sure that 6 Sigma is not being used during the validation activities.


Who will benefit:

Agenda


Day One

Lecture 1: Job Functions


Lecture 2: Quality Systems


Lecture 3: Quality Compliance


Lecture 4: Method Development and related activities associated with Technology Transfer - Quality Testing as well as Production


Lecture 5: Validation, Verification and on-going Cost Savings programs to generate Continuous Quality Improvement


Lecture 6: How to ensure an inspector is impressed while doing his/her inspection based on what the instructor helped with generating the quality systems inspector training - each student will get a copy of the workbook to be able to get their company in quick compliance.

Day Two

Lecture 7: Continued portion of 6 to ensure Quality Assessments are occurring in compliance with QSIT (statistics, incident tracking, 6 Sigma, audits, lab tests, inspections, document control, etc.)


Lecture 8: Quality Agreement regulatory requirements and vendor inspections


Lecture 9: Ensuring that all the above topics generate the proper "legal documents" that must be in compliance with the company's specific GDP requirements


Lecture 10: Ensuring that the Incident Tracking System and Customer Complaints are being properly managed to minimize patient risk (CAPA and Change Control Management, etc.)


Lecture 11: Regulatory requirements for setting up Procedures and BPRs / DHRs including the Master Records to make sure we are minimizing operator error and making the Document Review process more effective and cheaper prior to Product Release


Lecture 12: Using all the above to make adjustments to the company's regulatory submissions and the related DMF when applicable.

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Group participations
Get fabulous discounts by participating in groups of two or more.
Send two attendees: Get a discount of 10%!
Send three to six attendees: Get a grand discount of 20%!
Send seven to 10 attendees: Get a great discount of 25%!
Send more than 10 attendees: Get a whopping discount of 30%!
To avail the above group discounts, all the participants should register by making a single payment

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Venue


Location: Philadelphia, PA Hotel: DoubleTree by Hilton Hotel Philadelphia Center City   237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA Ph No - 215-893-1600

Speaker


Jerry Dalfors

Principal, JD Technologies and Coaching

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.

Local Attractions


Philadelphia, PA Local Attractions
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Philadelphia Museum of Art

This museum has perhaps the most dramatic location of any in the world being situated on a hill at the end of the Benjamin Franklin Parkway overlooking the Schuylkill. The building was constructed of a golden color stone in the 1920s and recalls the architecture of ancient Greece. Alas, the installation of elaborate multicolor sculpture for the triangular pediments was cut short by the Great Depression.

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Fireman's Hall

Stop by this small (and free!) museum on your walking tour of Philadelphia. Staffed by actual firemen, Firemans Hall exhibits artifacts, such as leather buckets and fire marks, once and sometimes still used to fight city fires.

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Philadelphia History Museum

Just steps from the Liberty Bell the new Philadelphia History Museum showcases an array of historical objects, art, and artifacts that tell the story of Philadelphia, from its founding in 1680 to present day. The Museum features eight renovated galleries, containing stunning items from its vast holdings of over 100,000 objects, and provides various interactive elements to enhance the visitor experience. On view are items ranging from George Washington�s 1790s writing desk to Joe Frasier�s 1970s Championship boxing gloves. Visitors can also take a tour of the city by walking on the world�s largest map of Philadelphia.

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National Museum of American Jewish History

The Museum offers tickets for Adults (ages 22-64) $12, Youths (ages 13-21) $11, Children (12-under) free, Active Military (with ID) free, Seniors (65+) $11. This museum offers dynamic and always intriguing exhibits. The history and evolution of the American Jewish community from colonial times onward is chronicled.

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Independence National Historical Park

One of the most famous square miles in the United States, the park is home to the Liberty Bell, the Tomb of the Unknown Soldier and Independence Hall.

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Kimmel Center for the Performing Arts

Kimmel Center, Inc., a charitable, not-for-profit organization, owns, manages, supports and maintains The Kimmel Center for the Performing Arts, which includes Verizon Hall, Perelman Theater, Innovation Studio and the Merck Arts Education Center. Kimmel Center, Inc. also manages the Academy of Music, owned by the Philadelphia Orchestra Association.

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Liberty Bell Center

The Liberty Bell originally hung in the tower of Independence Hall across the street. It continued to be used after the initial cracking when the fracture was enlarged to allow the bell to ring properly. However, additional cracking near the suspension point of the bell brought its useful life to a close. A new tower bell was installed and the Liberty Bell displayed in stair hall of Independence Hall.

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Boathouse Row

The best walking and biking route in the city is along the Schuylkill River. The cluster of 15 rowing clubs host a variety of rowing and running events each year.

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Independence Seaport Museum

Philadelphia's maritime museum features interactive exhibits, historic ships (Spanish American war-era cruiser Olympia and WWII-era submarine Becuna) and changing exhibition galleries. Seasonal river tours of the Delaware River and kayaks / rowboat rentals available. Extended evening hours Thursday - Saturday Memorial Day - Labor Day.