ComplianceOnline

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, and how to perform investigations to assure both compliance and good business decisions. The course stresses timely, consistent investigations focused on identifying the root cause and taking appropriate actions regarding the disposition of the data and the material, as well as corrective or preventive actions to avoid similar situations in the future. There will be an exercise using a participant's example to work through an investigation, as well as ample opportunity for questions and discussion.

Learning Objectives:

  • Be familiar with various terms used by regulators associated with investigations of atypical or out of specification results, and how to document those investigations.
  • Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
  • Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.
  • Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
  • Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.
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

Areas Covered:

  • Review of recent FDA Warning Letters regarding OOS results
  • Gauging the impact of OOS results
  • Get familiar with The FDA Guidance for Industry on Investigating OOS Test Results and the terminology inspectors will use
  • Initiating an Investigation
  • EXERCISE: Assess several examples to evaluate how much work is necessary
  • Conducting the Investigation
  • Documenting the Investigation
  • Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
  • EXERCISE: Discuss your challenging investigations and get feedback from the instructor and attendees
  • CAPA
  • Questions and Discussions

Who will benefit:

  • Supervisors and Managers in Pharmaceutical (Human or Veterinary
  • Chemists
  • Generic, OTC or Contract Laboratories
  • Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
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Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration Meet & Greet.
  • 9:00 -10:30
    • Seminar objectives review, expectations and scope.
    • Review of recent FDA Warning Letters regarding OOS results
    • Gauging the impact of OOS Results
    • Get familiar with the FDA Guidance for Industry on Investigating OOS Test Results
  • 10:30-10:45 Break
  • 10:45-12:00
    • Initiating the Investigation: Types of issues (OOS, Atypical, Stability, etc.)
    • When do you need to initiate and investigation?
    • When can you wrap up an investigation quickly?
    • WORKSHOP: Assess several examples to evaluate how much work is necessary
  • 12:00-1:00 Lunch
  • 1:00-2:30
    • Conducting the Investigation: Creating a Checklist, Root Cause Analysis, Retesting, Considering Other Batches
    • Documenting the Investigation
    • Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
  • 2:30-2:45 Break
  • 2:45-4:30
    • WORKSHOP: Discuss your challenging investigations, and get feedback from instructor and attendees
    • CAPA (Corrective and Preventive Action)
    • Utilizing Outcomes for Continuous Improvement
    • Additional Questions and Discussion
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Gregory P. Martin

Gregory P. Martin
President of Complectors Consulting LLC

Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.

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$699.00

Seminar One Registration

December 6, 2018, Philadelphia, PA

$3,199.00
$4,194.00 (23%)*

Save $995.00

Special Group Discount Register for Six attendees

December 6, 2018, Philadelphia, PA
*Hurry! This option is limited and based on availability.
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Your registration fee includes the workshop, all course materials.


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 $200 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 ($200) 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:

    Philadelphia, PA
    (Venue to be announced shortly)

    December 6, 2018

    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:

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    Local Attractions of Philadelphia, PA

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    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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