Skip To The Main Content

Raw Material Requirements (FDA/Health Canada/ICH/USP/EP) in a CGMP Environment: Issues and Solutions - New Course

Sep 27 - Sep 28, 2018
Washington, DC

The objective of this two-day highly interactive course is to explore raw materials and their requirements – issues and solutions.

  • Education

left to register

Time: 8:30 a.m. – 4:00 p.m.
Duration: 2 Days

Overview

Raw material requirements in a CGMP environment are often overlooked as a company develops new products. Depending upon the product being developed (e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products), as few as fifteen to twenty, or as many as sixty raw materials, need to be sourced before the process can be moved from initiation through completion. This highly interactive two-day course on raw material requirements in a CGMP environment will:

  • Consider FDA, Health Canada, ICH, USP and EP requirements
  • Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production
  • Cover testing requirements during each Phase (Phase appropriate), to include microbial and endotoxin, and what may be optional (regulatory risk) until the product moves to its next Phase
  • Determine what options exist - even within a Phase 2 or Phase 3 testing framework
  • Discuss compendial vs. non-compendial testing and how to respond when no method is available
  • Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing
  • Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route
  • Review the use of individual samples vs. composite samples for testing
  • Explore ASQ testing to include how to choose attributes and sample size

The objective of this two-day highly interactive course is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product, since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a CGMP compliance framework to include ICH Q7, Q9 and Q11. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Who Should Attend

Those who will benefit will include:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
  • R & D

Agenda

  • Upon completion of this course, you will be able to:

    • Explain how various types of raw materials may impact the user
    • Discuss the impact of raw materials to include any bacterial and endotoxin issues in the timely production of a product
    • Determine the single most used raw material in large molecule production and what it means to the user
    • Find the sources of analyses assistance for raw materials
    • Summarize the requirements for Phase 1 through commercial manufacturing—why safety is required as part of Phase 1
    • Discuss the initiation of additional testing -- when?
    • Examine regulatory risk to include ICH Q7, Q9 and Q11
    • Discuss why use compendial testing in lieu non-compendial testing
    • Examine testing requirements -- when is enough?
    • Explain the impact of ASQ on sample size and attribute testing

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Renaissance Washington D.C. Hotel

999 9th Street, NW
Washington, DC

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or before August 13, 2018
$1,743

After August 13, 2018
$1,937

Nonmember

On or before August 13, 2018
$2,092

After August 13, 2018
$2,324


Government/Health Authority/Academic

Member

$1,162

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 28, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Renaissance Washington D.C. Hotel
999 9th St NW
Washington, D.C. 20001 USA
Phone: +1 (202) 898-9000

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially