ComplianceOnline

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 12 hours of CE credit.

This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)

Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships. In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgement over the life cycle from early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by FDA and other regulatory agencies is important to assure timely approval, since GMP compliance issues can result in approval delays.

In this two day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.

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

Learning Objectives:

Upon completing this course participants should:

  • Understand the fundamentals of GMP for the United States
  • Understand how to determine what GMP-governed operations you are performing internally versus what you are outsourcing
  • Understand a method to structure your quality management system and decide which procedures you need now versus which ones can wait
  • Understand best practices for vendor management
  • Learn how to apply GMP concepts to Phase 1, 2 and 3 investigational drugs
  • Learn the differences between an FDA GMP inspection, a Pre-Approval Inspection and a Pre-License Inspection and where to obtain guidance for each
  • Understand basic principles of FDA inspection authority, what to expect if FDA inspects your virtual firm, and how to manage the presence of FDA personnel on site

Who will Benefit:

This course is designed for persons responsible for GMP compliance management following a virtual model, both pre- and post-market. Though designed with small company needs in mind, the principles are also useful to those in larger companies who manage CMOs, particularly those manufacturing investigational drug API and finished products:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Quality engineers
  • Quality auditors
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction and objectives
  • Virtual Company Challenges
    • Importance of quality management to business success
  • GMP defined and the Legal basis of GMP
    • Meaning of the term “Manufacturing”
    • CMO Role
    • Role of the contracting company
    • Specific GMP requirements that apply to virtual companies
  • Structuring a Quality Management System in a Virtual Company Setting
    • Structuring the organization and the Quality Unit
    • Structuring a document control hierarchy
    • Determining what procedures to have in place
    • Development of Quality Standards
  • Supply Chain Quality Management
    • Legal basis for this requirement of GMP
    • Vendor selection considerations
    • Quality Agreements
    • Vendor auditing system (frequency, depth, obstacles to overcome)
  • FDA Inspections of Virtual Companies
    • Authority and scope of access
    • Reasons for FDA inspections of virtual companies
    • Special considerations for Prre-Approval (NDA/BLA) inspections
    • Logistic considerations for managing FDA presence on site
    • Answering interview questions
    • Regulatory correspondence: Responding to FDA-483s, other post inspection correspondence
Day 02(9:00 AM - 4:00 PM)
  • 09.00 AM: Session Start
  • Phase Appropriate GMP Compliance
    • Legal basis
    • Applicability to placebos
    • FDA vs. EMA inspection considerations
  • FDA Guideline for Phase 1 GMP Compliance
  • FDA Guideline for Phase 2 and 3 GMP Compliance (legacy 1992 guideline no longer applicable to Phase 1)
  • EU Annex 13 – Investigational Medicinal Products
  • Importance of Data Integrity
  • GMP data versus “application data” and importance to PAI/PLI Success
  • Practical application of GMP principles to investigational drug manufacturing
    • Facility considerations – size, scale
    • Equipment qualification
    • Process and analytical method validation issues
    • Scale-up issues
    • Sterility and environmental control
    • Stability issues
    • Procedures – level of detail
    • Master and batch production and control records
    • Change control – at what point does this apply?
    • Deviation investigation
    • Batch disposition and role of the Quality Unit at the CMO vs the Virtual Company
  • Final discussion, Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
David L Chesney

David L Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.

Mr. Chesney has an MS degree in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

Seminar One Registration

March 26-27, 2020, Irvine, CA
(Registrations till December 15, 2019 - $1499)
(Registrations after December 15, 2019 - $1899)




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

Your registration fee includes the workshop, all course materials and lunch.


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

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ customercare@complianceonline.com

Payment:
Payment is required 2 days before 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 $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) 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 5 working days before 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 ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Irvine, CA
    (Venue to be announced shortly)

    March 26-27, 2020

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Testimonials

    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

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner


    Hospitals-Management is essentially a B2B online business and media platform that has under it wraps the largest global database of Healthcare buyers and suppliers. Hospitals-Management.com covers in-depth trends that shape industry dynamics and metamorphose global economics.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Local Attractions of Irvine, CA

    The Irvine Museum

    The Irvine Museum

    The Irvine Museum collects and preserves California Art, with an emphasis on landscapes and Impressionist work. The Museum itself is a lovely hacienda style building, reminiscent of the Golden Land's early days.

    Tanaka Farms

    Tanaka Farms

    Located in the heart of sunny Irvine, Tanaka farms provides fun, educational activities for kids and families. Seasonal tours of the Pumpkin Patch and Strawberry Fields, plus elaborate cook-outs and entertainment are among the delights offered at Tanaka farms.

    Pretend City Children's Museum

    Pretend City Children's Museum

    Pretend City Children's Museum is a very promising place to bring children.

    Orange County Great Park

    Orange County Great Park

    The Orange County Great Park is a vital center that brings together some of the southern California's exciting, diverse communities with educational workshops, farmer's markets, concerts and exhibits. The Park is currently expanding and will soon have an elaborate sports field as well.

    Disneyland />
	<p class=Disneyland

    One of the largest and most popular Orange County attractions is just a short trip away. See Mickey, Minnie, Peter Pan, Winnie the Pooh, Alice in Wonderland and many of the world's most beloved characters and rides during a visit to the Magic Kingdom.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We need below information to serve you better

    Best Sellers
    You Recently Viewed
      Loading