ComplianceOnline

Register

Toll Free: +1-888-717-2436




Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation: One and a Half-day In-person Seminar

By:
Dr. Joy Frestedt, PhD, CCTI, RAC, FRAPS
Coming soon.. Please contact customer care for new schedule

Course Description:

Course "Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation" has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.

The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product.

This course will review two FDA websites and the three FDA guidances pertaining to DMFs

  • Drug Master Files (DMFs)
  • 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files
  • Drug Master Files: Guidelines
  • Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances
  • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research

Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the course will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation.


Learning Objectives:

  • Understand the two FDA websites and three FDA guidance documents regarding DMFs.
    • Drug Master Files (DMFs).
    • 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files.
    • Drug Master Files: Guidelines.
    • Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances.
    • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.
  • Review the five types of DMFs and their uses.
  • Able to develop the information to be contained in the DMF.
  • Understand when the DMF should be filed with the FDA.
  • Be able to describe experiences of others regarding real world issues associated with creating and submitting DMFs.
  • Able to use a checklist to construct a DMF from scratch.


Who will Benefit:

  • Manufacturing
  • Regulatory Affairs
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials



Course Outline:

Day One     Day Two
  • Introductions (15 Min)
    • Instructor
    • Participants
  • Session 1: DMF s (75 min)
    • What is it?
    • Who benefits from them?
    • Relationship to drug and biological applications
    • Definitions
    • 2 FDA website reviews
    • 3 Guidance document overviews
  • Break (30 Min)
  • Session 2: Types of DMF (30 min)
    • Type 1: Manufacturing (retired)
    • Type 2: Drug Substance
    • Type 3: Packaging
    • Type 4: Excipients
    • Type 5: Other
  • Workshop: Defining the type of DMF to submit (90 min)
  • Lunch (60 Min)
  • Session 3: Drug Master File Contents (60 Min)
    • Administrative requirements
    • Technical Requirements
  • Break (30 Min)
  • Session 4: Relationship between DMFs and current Good Manufacturing Practices (cGMPs) (30 min)
  • Case Study: Determining the supporting evidence for a submission (90 Min)

   
  • Day 1 Recap (15 min)
  • Session 5: FDA Submissions (60 Min)
    • What to include and what not to include
    • Format
    • Essential information
    • Key documents
    • Assembly/ Binder Specifications
    • Delivery
  • Workshop: Creating a checklist (60 min)
  • Break (30 Min)
  • Session 6: Ongoing obligations (30 Min)
    • Changes to DMF
    • Transfer of ownership
    • Closure of a DMF
    • Retirement of DMF
  • Q&A and Conclusions (45 min)




Meet Your Instructor

Joy Frestedt, PhD, CCTI, RAC, FRAPS
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.




Register Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation: One and a Half-day In-person Seminar".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Venue

Hotel:

Special Offer for the attendees of this seminar:

Call 1-877-734-2726 and give promo code #338671 to get 20% discount on Hotel room at Sheraton San Diego Hotel and Marina.

Hotel rooms are limited and based on availability.




View Larger Map


How to Reach

General Directions to the Hotel

From East
  • Take Interstate 8 West to I-5 South.
  • Take the Sassafrass/San Diego Airport Exit.
  • Turn right onto Laurel.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.
From North
  • Take Interstate 5 South to the Sassafrass/San Diego Airport Exit.
  • Turn right onto Laurel.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.
From San Diego International Airport
  • Follow the exit which becomes Harbor Island Drive.
  • Drive straight through the intersection to Harbor Island Drive.
  • The hotel is on the right-hand side.
From South
  • Take Interstate 5 North to the Hawthorne/San Diego Airport Exit.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.

Airport

Brown Field Municipal Airport (SDM)
Travel Distance: Approximately 0.02 km/0.01 miles

San Diego International Airport (SAN)
Travel Distance: Approximately 1.61 km/1.0 miles

Montgomery Field (MYF)
Travel Distance: Approximately 11.27 km/7.0 miles

Railway

Santa Fe Depot
Travel Distance: Approximately 4.83 km/3.0 miles

Bus

Greyhound Bus Station
Travel Distance: Approximately 2.82 km/1.75 miles

Other

Downtown
Travel Distance: Approximately 4.83 km/3.0 miles





Accreditation




The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.




After completion of course "Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation" RAPS certificate will be issued to attendee.





Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

 



Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.




Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.




Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.




The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.




Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.




Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.




In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.





We need below information to serve you better