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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar

Dr. Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research
Location 1:-
San Francisco, CA

Thursday, March 24, 2016 | Friday, March 25, 2016
Location 2:-
Philadelphia, PA

Thursday, August 18, 2016 | Friday, August 19, 2016

Course Description:

Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements.

The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Issues specific to special products in early stages of development such as combination products and 505(b)(2) drugs will be discussed. Basics of process validation along to standard process development will be presented. Perspectives for different classes of products will be presented using case studies.

Who will Benefit:

  • Directors
  • Managers
  • Supervisors, and lead workers in Regulatory Affairs
  • Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products as well as those who will review these documents
  • Regulatory affairs workers who will need to deal with submissions covering early phase products.

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline and Approximate Times:

Day 1 (8:30 AM – 4:00 PM) Day 2 (8:30 AM – 3:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 – 10:30 AM: Lecture 1: Moving a Product out of R&D
    • Issues with research grade material used for laboratory and non-clinical testing
    • Optimizing manufacturing processes
    • Raw material requirements and process development
    • Assessing scalability of manufacturing
    • Planning the CMC for a potential IND
  • 10:30 – 10:45 AM: Break
  • 10:45 – 12:30 noon: Lecture 2: CMC Requirements for an IND Study
    • Essential elements of the CMC section of an IND
    • Characterization of the active ingredient and finished product
    • Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
    • Manufacturing facility, personnel and equipment requirements
  • 12:30 – 1:15 PM: Lunch
  • 1:15 – 2:45 PM: Lecture 3: Good Manufacturing Practices: Basics for Beginners
    • Core principles of GMP
    • Regulatory requirements for different products: drugs to medical devices
    • Customizing regulatory compliance to a given product
    • Role of discussions with the FDA
  • 2:45 – 3:00 PM: Break
  • 3:00 – 4:00 PM: Lecture 4: Raw Material Management
    • Planning for the early stage with an eye towards large scale manufacturing
    • Vendor management
    • Raw material handling issues for early stage products
    • Manufacturing step development
  • 8:30 – 10:00 AM: Lecture 5: GMPs for Phase 1 IND products
    • The scope of the FDA guidance document
    • Acceptable practices and practical tips
    • GMP requirements for exploratory clinical studies
    • Specific requirements for drugs, biologics and combination products
  • 10:00 – 10:15 AM: Break
  • 10:15 – 12:00 noon: Lecture 6: GMPs for Combination Products and 505(b)(2) Products
    • Specific issues for various kinds of combination products
    • Combination products with one or more new components
    • CMC issues for 505(b)(2) products
    • GMP and QSR: which to follow for a combination products
  • 12:00 – 12:45 PM: Lunch
  • 12:45 – 2:15 PM: Lecture 7: Process Validation for Early Stage GMP
    • Introduction to process validation for early stage manufacturers
    • Step by step instructions for process validation
    • Process validation reports and other documentation
    • Developing SOPs based on validation processes
  • 2:15 – 2:30 PM: Break
  • 2:30 – 3:30 PM: Lecture 8: Outsourcing Early Stage Manufacturing
    • Logistics of using contract manufacturing organizations for early stage products
    • Pilot scale manufacturing requirements
    • GMP-grade and non-GMP grade manufacturing
    • Benefits and challenges with using local and international vendors

Meet Your Instructor:

Dr. Mukesh Kumar
Senior Director, Regulatory Affairs, Amarex Clinical Research

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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Seminar One Registration

March 24-25, 2016, San Francisco, CA
(For Registrations till December 20, 2015 - $1299)
(For Registrations till January 30, 2016 - $1399)
(For Registrations till February 15, 2016 - $1499)
(For Registrations till March 10, 2016 - $1599)
(For Registrations after March 10, 2016 - $1699)

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March 24-25, 2016, San Francisco, CA
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(With Stay) Seminar One Registration

March 24-25, 2016, San Francisco, CA


Seminar One Registration

August 18-19, 2016, Philadelphia, PA
(For Registrations till December 20, 2015 - $1299)
(For Registrations till January 30, 2016 - $1399)
(For Registrations till February 15, 2016 - $1499)
(For Registrations till March 10, 2016 - $1599)
(For Registrations after March 10, 2016 - $1699)

Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; tea/coffee and lunch on both the days.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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10+ Attendees - Get 30% off

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What past attendees say:

I enjoyed the practical answers and lessons learned as shared by the presenter. Grateful for the sharing of presentation material (soft copy). Thanks to ComplianceOnline for timely response and communication. Variety of choices is extensive good and easy to register.
- Manager, Process Optimization, Prolong Pharmaceuticals, LLC

Excellent instructor and he was easy to follow and I like the thorough and thoughtful answers of my questions.
- Senior Scientist, CCS Associates

Instructor is very knowledgeable and good in explaining regs and guidance. Information provided along with soft copy of slide is a great idea and very helpful.
- Sr. QA Manager, Theravance

Overall a good general overview. The amount of interaction between the participants and presenter was good.
- Asst. Director QA, Clinical Packaging, Abbott Labs

GMP expectations was the most valuable topic for me. Face to face interaction and networking was good.
- Director of Pharmacy, Pfizer New Haven Clinical Research Unit

Speaker’s knowledge was higher than I had hoped.
- Director, BioMed IRB

For me the whole event was very good. I had no knowledge of the topic prior to this seminar. The presentation was excellent and the speaker was very knowledgeable and respectful.
- Quality Assurance Specialist, Therapure Biopharma Inc.

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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San Francisco, CA, Local Attractions

Philadelphia, PA, Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

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Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

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