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2-day In-person Seminar

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials


July 27th & 28th, 2017

Time: 9:00 AM to 6:00 PM

Philadelphia, PA

Venue: Hilton Garden Inn Philadelphia Center City


Director : Peggy Berry

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

  Register for 10 attendees   Price: $8,222.00
      $14,950.00 You Save: $6,728.00 (45%)*
Course "FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.


Why should you attend:

To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.


Areas Covered in the Session:

Seminar Day 1

The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.

  • Moving a Product out of R&D
  • CMC Requirements for an IND Study
  • Good Manufacturing Practices: Basics for Beginners
  • Raw Material Management

Seminar Day 2

The following topics will be discussed to provide the requirements for early stage products of different types and for vendor selection and management.

  • GMPs for Phase 1 IND products
  • GMPs for Combination Products and 505(b)(2) Products
  • Process Validation for Early Stage GMP
Outsourcing Early Stage Manufacturing

Day 1 Schedule


Lecture 1:

Issues with research grade material used for laboratory and non-clinical testing


Lecture 2:

Optimizing manufacturing processes


Lecture 3:

Raw material requirements and process development


Lecture 4:

Assessing scalability of manufacturing


Lecture 5:

Planning the CMC for a potential IND


Lecture 6:

Study Essential elements of the CMC section of an IND


Lecture 7:

Characterization of the active ingredient and finished product


Lecture 8:

Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices


Lecture 9:

Manufacturing facility, personnel and equipment requirements


Lecture 10:

Core principles of GMP Regulatory requirements for different products: drugs to medical devices


Lecture 11:

Customizing regulatory compliance to a given product


Lecture 12:

Role of discussions with the FDA


Lecture 13:

Planning for the early stage with an eye towards large scale manufacturing


Lecture 14:

Vendor management


Lecture 15:

Raw material handling issues for early stage products


Lecture 16:

Manufacturing step development

Day 2 Schedule


Lecture 1:

The scope of the FDA guidance document


Lecture 2:

Acceptable practices and practical tips


Lecture 3:

GMP requirements for exploratory clinical studies


Lecture 4:

Specific requirements for drugs, biologics and combination products


Lecture 5:

Specific issues for various kinds of combination products


Lecture 6:

Combination products with one or more new components


Lecture 7:

CMC issues for 505(b)(2) products


Lecture 8:

GMP and QSR: which to follow for a combination products


Lecture 9:

Introduction to process validation for early stage manufacturers


Lecture 10:

Step by step instructions for process validation


Lecture 11:

Process validation reports and other documentation


Lecture 12:

Developing SOPs based on validation processes


Lecture 13:

Logistics of using contract manufacturing organizations for early stage products


Lecture 14:

Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing


Lecture 15:

Benefits and challenges with using local and international vendors

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

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Peggy J. Berry


Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

Location: Philadelphia, PA Hotel: Hilton Garden Inn Philadelphia Center City   1100 Arch St, Philadelphia, PA 19107, United States

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