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									                              Pharmaceutical Auditor
                              Quality Accreditation Program
                              Pharmaceutical Skill Enhancement

Our staff has amassed more than half a century’s worth of experience and knowledge dealing with Out-
of-Specification, Manufacturing, Laboratory, Stability, Environmental and Utility issues in the drug
product and drug substance pharmaceutical industry. In today’s regulated environment, it is
increasingly more important to obtain the skill sets necessary to make quality conscience and compliant
decisions.

Pursuant to achieving this goal, Insight Compliance Training Group has agreed to sponsor an extensive
multi-course accreditation program targeted for pharmaceutical (or related industry) auditors. This
program provides the following assistance to the quality operations:

   Examine all activities pertinent to effectively audit work required in a pharmaceutical operation –
    receipt, handling, testing, validation, maintenance, documentation, training, etc.

   Answer specific questions regarding quality programs, tests, systems

   Provide guidance for procedures, training, qualification and testing



         Your Training Package will include:
                      26 Reference Booklets
                   18 PowerPoint Presentations
                           SOP Templates
                    FDA Documents on Audits
             DOE Guides on Training, Documentation
           Audit Checklists on Filings, Labs, Operations
     An Opportunity for our Experts to Review and Comment on
                          Two Audit Reports
                          Audit Checklists
      An Opportunity for our Experts to Accompany You on an
                Audit – Either Internally or Externally



                                               Page 1 of 4
                      Overview of the Program:
  A total of 26 training booklets, numerous guides, SOPs and PowerPoint presentations will be
   issued to each group for review.

  An assignment will be issued at agreed upon intervals based upon the booklets.

  It is the responsibility (assignment) of the group to review each booklet, evaluate their unique
   situation and prepare any questions. Typically, two to three booklets are reviewed per session.

  At the agreed upon date and time, personnel attending the accreditation program will be required
   to call a personalized coach who will discuss the pertinent topics, apply the topics to each unique
   situation and answer any questions. There will be a maximum of three (3) personnel participating
   in each coaching session. Each phone call will last approximately one (1) hour.

  The one (1) hour phone call will consist of approximately 15 minutes for review by the coach of the
   topic, approximately 30 minutes for situation applications and approximately 15 minutes for Q&A.

  Personnel are allowed up to five (5) e-mails per training session to ask questions regarding any
   previously discussed topics.

  If coaching sessions are missed, make-up times/dates can be scheduled.

  At any point during the training, personnel can forward up to a total of four investigation reports for
   review and comment. A confidentiality agreement can be implemented prior to any discussions
   on sensitive issues.

  Part of the accreditation process is an ON SITE audit. This has to be arranged at least four weeks
   in advance and will last for one – two days. Additional days may be needed and will require
   discussions at the onset of the program. Part of passing the audit is the response to any
   observations!

  To obtain accreditation, firms are required to participate in each weekly phone discussion and pass
   an audit. If at any point during the training that the coach or auditor feels that there is a serious
   problem, it will be immediately brought to your attention. Our goal is to RESOLVE any issues, not
   to fail the firm. On the same note, we will not overlook or perform an “easy” audit just to present
   the firm with an accreditation.

  This accreditation signifies that you have passed through a rigorous program of training and
   auditing. A certificate will be issued and will expire one year after issue date. To re-certify, a one-
   day audit will be conducted.

Price: $4,999 for the accreditation plus travel.




                                              Page 2 of 4
Booklet and Coaching Topics:
   I.   The Basic Elements of an Investigation      XIII.    Pharmaceutical Cleaning
  II.   Quality Agreements                          XIV.     Prevention of Cross Contamination
 III.   GMPs – 21 CFR, Parts 210, 211 and 11        XV.      Quality Systems
 IV.    Validation                                  XVI.     Preparing for the Audit
  V.    Change Control                             XVII.     Corrective Actions
 VI.    Packaging, Labeling, Receiving and         XVIII.    The Quality Audit
        Warehousing                                  XIX.    Quality Tools
VII.    Documentation Systems                         XX.    Product Acceptance Sampling
VIII.   The Batch Record                             XXI.    Annual Product Review
 IX.    The Barr Decision                            XXII.   Stability
  X.    Filtration – HEPA and Process               XXIII.   Computer System Validation
 XI.    Training                                    XXIV.    Tablet Standards
XII.    Calibration Planning                        XXV.     Stainless Steel Reference Standard
                                                    XXVI.    ICH Q7a
        As a Bonus, you will receive a two-month free subscription to the
                        FDA Warning Letter Database:
                 SOP’s                                     PowerPoint Presentations
         Annual Product Reviews                         FDA Systemic Inspection Approach
               Part 11 Series                            Facility, Utility and Environmental
             OOS Investigations                                         Monitoring
            Good Housekeeping                                          GMPs
          Labeling Reconciliation                             Interacting with the FDA
          Calibration Master Plan                                  Internal Audits
              SOP Numbering                                   Annual Product Review
       GMP Documentation Storage                                  Batch Records
      Deviation Investigation Reports                     Process Analytical Technology
    Cleaning Validation Requirements                           Preparing for the Audit
     Cross Contamination Prevention                                 Root Cause
      Equipment Quality Parameters                                 Investigations
             Retention Samples                              FDA 483, Warning Letters
           Customer Complaints                                 Reference Guides
                   Recall                               Inside the Mind of the FDA Binders
         Facility Utility Interruption                   New Employee GMP Orientation
         Pest and Rodent Control                               PAI Survival Package
        Maintenance Work Orders                           DOE – Root Cause, Equipment
      Outline of Validation Protocols                              Labeling, Training
           Qualification Program                             Barr Decision Transcripts
     GMP Document Storage Guides                       FDA Laboratory Procedures Manual
               Label Control                           FDA Compliance Program Guidance
  Labeling Verification during Packaging                    FDA Guides to Inspections
                                                       FDA Guide to Water Inspections

                                            Page 3 of 4
                                     Application
Please complete this application in its entirety. The person listed below will be the main contact point
for all correspondence.

Title:   Mr.   Mrs. Ms. Dr.

First Name: ________________________Last Name:_______________________

Company Name:_____________________________________________________

Job Title:___________________________________________________________

Business Address:___________________________________________________

City:___________________State:______________Zip_____________Country:______________

Day Phone:_______________________ Fax #:____________________

E-mail:____________________________________________________

Company Description (include fliers, websites, etc.)____________________________________

Maximum Education Level:___________________________________

List any other pertinent information:________________________________________________

____________________________________________________________________________

Payment Method:     Visa, MasterCard or Amex

Card Number:____________________________________Exp Date:_________________

Signature:______________________________________________________

Fax or mail to:
Compliance Insight, Inc.
Pharmaceutical Auditor Accreditation Program
5850 Boymel Drive, Suite 1
Fairfield, OH 45014
Phone: 513-860-3512
Fax: 513-860-3406
e-mail: carol@compliance-insight.com
Website: www.compliance-insight.com




                                              Page 4 of 4

								
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