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Pharmaceutical Manufacturing

Title QA Needs Assessment
Description This project identified the managerial and quality training needs of quality assurance professionals working in a Pharmaceutical Production Department.
   
Title

CBT Program Design Workshop

Description This project provided trainers with competency-based program design skills.
   
Title

Foundation Training II

Description This training designed six modules covering the basics of pharmaceutical manufacturing. These self-instructional programs were designed to give new and incumbent employees a solid foundation on the principles and steps required for safe, efficient and GMP-compliant manufacturing of finished pharmaceuticals.
   
Title

New Supervisor Training

Description This project provided an 8-hour one-day training program for new, exempt supervisors.
   
Title Foundation Training
Description This program consisted of a series of self-study courses designed to train operators on the basics of pharmaceutical manufacturing.
   
Title Time Management Workshop
Description This workshop presented the basic concepts of time management to facility maintenance engineers and mechanics.
   
Title

Training Program Design

Description This program ensured that an up-to-date training system was in place within the manufacturing facility.  To meet this goal, a Strategic Training Plan was developed and implemented within the manufacturing department including technical skill training checklists.
   
Title Manufacturing Training Plan
Description This in-depth study determined the compliance training needs of a pharmaceutical manufacturer.  The result of this Needs Assessment was a detailed Training Plan and Implementation Schedule.
   
Title Training System
Description This project involved developing a training system that included SOP and training update functions to respond to the continuous refinement of processes and procedures in this biotech manufacturing environment.
   
Title

Research and Development Training Plan

Description This training plan required an in-depth study to determine the training needs of a pharmaceutical research and development facility, and development of a detailed action plan for pursuing the recommended changes and additions to existing training.
   
Title Consulting Services
Description In this project we developed a lesson plan for Aseptic Techniques as a pilot training
program.
   
Title Cleaning and Sanitization SOP
Description This program redeveloped the Cleaning and Sanitization SOP at the company’s facility in Seattle, WA.
   
Title

TPD Services

Description The purpose of this project was to provide structured, competency-based technical skill training programs to production personnel.
   
Title Competency-Based Training Program Design
Description The purpose of this program was to develop competency-based training programs to support the production of the Anthrax vaccine.
   
Title Pharmacy Technician Task Analysis
Description This task analysis offered a detailed description of core competencies required for ingredient handlers in this consumer product manufacturing facility.
   
Title Training Programs for Manufacturing Operators
Description This project included a comprehensive training program complete with a Leader's Guide, job aids, videos, and reference materials for five packaging operations including Cartoner, case wrapper, and bottle washing.
   
Title

Packaging Line Job Aids

Description This project involved task analyses of multiple packaging line job functions, and development of 2' x 3' wall-mounted graphics to assist operators in handling technical difficulties.
   
Title

Needs Assessment

Description This project included a facility-wide assessment of compliance training needs with a comprehensive Strategic Training Plan including implementation schedule and facilitation support.
   
Title

Technical Training Services

Description This training developed a Media Preparation Training Guide and conducted Train-The-Trainer Certification workshop.
   
Title

GMP Training for Executives

Description This training produced a four-hour classroom training program with discussion and a question-and-answer session led by former FDA auditors.
   
Title

Train-the-Trainer

Description This comprehensive one-week program was used to train personnel on how to design and lead effective training programs.
   
Title

Manufacturing Training Plan

Description This in-depth study determined the training needs of a pharmaceutical manufacturer.  The result of this needs assessment was a detailed training plan and implementation.
   
Title GMP Training for Quality Assurance and Quality Control Personnel
Description This two-hour workshop provided participants with theory, case studies, small group discussions, and a question-and-answer session led by former FDA auditors.
   
Title

GMP for Operators, Technicians, and Mechanics

Description This three-hour workshop covered all subparts of CFR 2.10 and 2.11.  Included were exercises and activities designed to help participants improve their GMP compliance in the workplace.
   
Title Needs Assessment
Description This project involved a plant-wide assessment of all manufacturing personnel in a facility that makes blood derived products. The analysis included written questionnaires and personnel interviews of all personnel.  Personnel in the analysis were from manufacturing, maintenance, laboratory, and warehousing.  A comprehensive training plan for the entire site was developed.
   
Title GMP Training
Description This GMP Training Program was developed to educate personnel on the New Aseptic Process Guidance.  This program was designed to be completed in two hours and contained interactive exercises for up to 30 participants.
   
Title EU vs.Us Workshop
Description This GMP Training Program was developed to educate personnel on a comparison of US and EU GMP’s and implications. The program contained interactive exercises for up to 30 participants and is designed to be completed in two hours. An assessment was also included.
   
Title GMP Self-Study
Description In this project we developed a GMP Training Program to educate personnel in correct GMP procedures. This program was designed to be completed in one hour with a 30-minute, instructor-led follow-up.
   
Title

Needs Analysis

Description This project included comprehensive interviews of Sales, Sales Management, Sales Training, Health Economics, and Market Research to identify required competencies/best practices and curricula for reimbursement and site-of-care issues for the sales force.
   
Title Standard Operating Procedures
Description This project developed a Standard Operating Procedure Manual for Biological Research and Laboratory Operations.
   
Title Facility Audit
Description This project evaluated the safety, environmental, and health needs of a laboratory and manufacturing facility.
   
Title Chemical Hygiene Plan
Description This assignment required a comprehensive Chemical Hygiene Plan which met OSHA
safety standards for a laboratory environment to be designed and developed.
   
Title Safety Manual
Description This project involved the development of the Safety Policies and Procedures Manual.
   
Title Compliance Workshop
Description This program designed a one 60-minute interactive workshop for up to 40 participants to develop new competencies in the field force related to knowledge of compliance procedures, the overall compliance, and the current compliance enforcement environment.
   
Title

PeopleSoft Order Management

Description This project included a comprehensive training plan to design modularized materials for both classroom and on-the-job training.
   
Title GMP Training
Description This job involved the development of self-instructional GMP training.
   
Title Train-the-Trainer
Description This training taught existing/new trainers basic technical training techniques.  The session included individual counseling and videotaping of practice presentations.
   
Title

GMP Meeting Series for Medical Devices

Description This project involved developing online training to provide certification to employee’s manufacturing medical devices.
   
Title PeopleSoft
Description This project involved designing end-user training for a PeopleSoft implementation in Puerto Rico and conducting a prerequisite Microsoft Windows training for all applicable plant personnel.
   
Title EHS  Manual Creation and Revisions
Description Created and revised EHS elements as directed by Nuclear Pharmacy.
   
Title Change Control
Description This project developed a change control policy and procedures and maintained documents for Health Pharmacy Operations.
   
Title

Policy Manual

Description

This job involved rewriting the Policy and Procedures Manual for the company’s Health's Nuclear Pharmacy Operation. Policies and procedures had to be separated, SOPs written, and the entire manual reorganized.

   
Title

Training Manual 2007 Update

Description

This training program created and updated Training Manual as directed by Nuclear Pharmacy.

   
Title

QC Manual - 2007 Update

Description

This project created and updated QC Manual as directed by Nuclear Pharmacy.

   
Title

Training & Orientation Manuals Integration Into LMS

Description

This training program converted all company’s Training & Procedures documentation into a format compatible with the company’s LMS.

   
Title

Policy & Procedures. Manual-2007 Update

Description

This training program created and updated Policy & Procedures Manual as directed by company’s Nuclear Pharmacy.

   
Title EHS Manual - 2007 Update
Description This training program created and updated EHS Manual as directed by company’s Nuclear Pharmacy.
   
Title

Policy & Procedures Manual Revisions and Update

Description

This project training program created and updated Policies and Procedures as directed by company’s Nuclear Pharmacy.

   
Title

Global Quality Curriculum

Description

This project developed the Quality Curriculum and required technical skills training programs for the company's Global Quality operations.

   
Title

Supervisor Handbook

Description

This training program revised, reformatted, and updated the QA Supervisor Handbook—as well as developed a management presentation on the use of the handbook.

   
Title

Packaging

Description

This project was to design and develop structured, competency-based, training programs. Training programs were developed for: Marketed Packaging, Clinical Packaging, and Inspection.

   
Title

QA Training Curriculum

Description

The purpose of this project was to develop a curriculum for the QA department and the specific job training programs associated with the curriculum.

   
Title QA Validation Approver
Description This project developed a competency-based training program for QA Validation Approvers,
compatible with company’s learning management system—gLearn.
   
Title

Cell Banking Training

Description

This project identified the knowledge and skills involved in the Cell Fermentation process.  Once this information was identified and structured, competency-based training programs with corresponding evaluations were developed for the process.

   
Title

Learning Management System (gLEARN)

Description

This project reduced the time it takes personnel to manage and access training records and to build support for the introduction of an LMS.

   
Title

Quality Overview

Description

This training developed a 1-1/2 hour, instructor-led training course providing an overview of their Quality Systems. This course emphasized patient safety and the importance of the quality systems to maintain control and establish consistency in business processes, references to regulations, examples in day-to-day applications; and inspection technique with added emphasis on the importance of robust quality systems.

   
Title Training Audit Program
Description This project evaluated GMP training programs at their California locations to ensure they are competency-based and meet criteria evaluated by the FDA.
   
Title

Technical Writing

Description

This project involved designing a 3-day custom technical writing workshop, we designed the Leader's Guide, and delivered the training.  Included in the program were intensive practice with expert feedback on actual SOP documents that participants would develop in the workplace.

   
Title

GMP (Good Manufacturing Practices) Meeting Series

Description

This web-based application is based on the GMP regulation. It is an interactive, one-hour program designed to introduce employees to all aspects of GMPs.

   
Title

Visual Workplace

Description

This training developed competency-based Visual Workplace Instructions for personnel at manufacturing facilities in SC and NC.

   
Title

QA/QC Curriculum Development

Description

This project developed a curriculum for Quality Assurance and Quality Control and the support training programs for personnel at a pharmaceutical manufacturing facility.

   
Title Chemical Operator Curriculum
Description This project conducted a task analysis that identified the core competencies for chemical operators and translated the competencies into job specific skills and areas of knowledge.
   
Title Operator Certification Program
Description This plant wide competency-based technical skills training was used to address FDA requirements for personnel working in Ingredient Handling, Granulation, etc.  The program consisted of Leader's Guides based on task analyses, knowledge, and skill.
   
Title

Product Knowledge Videotape

Description

This videotape was created to highlight the advantages and disadvantages of the product for sales representatives.  It included the indications and contraindications for the product.  In addition, the pharmacokinetics of the product were described.  Particular attention was devoted to discussing the effects of excessive dosing and liver dysfunction.

   
Title

Needs Analysis and Training Plan

Description

This project included a comprehensive Training Needs Analysis and the development of a Strategic Compliance Training Plan for all of manufacturing.

   
Title

cGMP Compliance and QC Lab Training Program

Description

This training developed and presented current Good Manufacturing Practices as they relate to QC Laboratories.

   
Title Blow Mold Machine Operator Certification Program
Description This self-instructional, competency-based training program was used for operators of new injection molding machines.  The program consisted of self-instructional text based on computer task analysis and tests of knowledge and skill.
   
Title

Set-Up Mechanic Training Program

Description

This training program was designed for set-up mechanics who work with the Merrill
Filler, New Jersey Labeler, and Jones Cartoner.

   
Title

Thiele Traying Machine Change-Over Manual

Description

This self-instructional manual instructed personnel on how to change-over the Thiele Traying Machine.

   
Title

Laboratory Analyst Equipment Training

Description

This self-instructional program was designed to train analysts on various laboratory equipment.

   
Title

Straight-Through Packaging Mechanical Technician Training Program

Description

This competency-based training program was used to qualify mechanical technicians new to the facility packaging process.

   
Title

Adtech Bottle Feeding, AirWash and Filling Machine Training Program

Description

This classroom-based training program was designed to teach operators to assemble the Adtech machine, set controls for any specified product, disassemble, clean, and inspect the machine after use.

   
Title

Blow Mold Machine Task Analysis

Description

This analysis identified the steps necessary to operate and change-over bottle making equipment.

   
Title

Order Writing

Description

This training provided two instructors to learn and present the newly acquired QUMAS software system for Standard Data and Order Writing. Three types of training were delivered: a 2-day author's course; a 1/2-day approver course; and a 1/2-day order package generator (OPG) course.

   
Title

Packaging Line Task Analysis

Description

This project involved conducting a task analysis for high-speed and manual packaging lines.  The project involved 23 different work process areas and machines.

   
Title

Machine Training Program

Description

This state-of-the-art interactive video instructional program was aimed at teaching employees to use the company’s blister-pack machine.

   
Title

Web-based Quality Assurance Application

Description

This program designed and developed a web-based application for Quality Assurance personnel throughout the world to ensure standards were communicated to all Quality Assurance employees.

   
Title

Overview of Drug Product Development
.

Description

This project developed a training program that explains drug product development process.

   
Title SOP Training
Description This project included writing training for a laboratory SOP on Chromatography system suitability. Deliverables included self-instructional materials
   
Title

Bolus Manufacturing Training Program

Description

This competency-based training program was used to train operators how to set up, start, run, troubleshoot and clean in-place the entire manufacturing line for a unique veterinary product.

   
Title

H and K Encapsulator Training Program

Description

This self-instructional, competency-based training program was used to train operators on H and K Encapsulating equipment.  This program covered set-up, start, run, troubleshooting, and clean in-place.

   
Title

Business Acumen

Description

This training developed a Business Acumen 3-day classroom-based training/workshop for Business Managers.

   
Title

Quality Auditor Web Site

Description

This web site was designed to be used by their company’s quality auditors around the world to promote the adoption of best practices, to provide a consistent approach to quality issues, and to save time by providing templates, samples, and other reference documents. 

   
Title

Validation Training

Description

This project included the development of training for the new SOP and guidelines for equipment IQ/OQ.  There were two instructor-led workshops; a 1.5-hour overview for the entire facility, and a 8-hour in-depth session for SOP users that included the theory of validation, the details of the new procedures, and practice sessions for using the new templates.

   
Title CBT- Cancidas Manufacturing
Description This comprehensive competency-based training curriculum and operator qualification system for Cancidas manufacturing included:  self-study, classroom, and on-the-job components.
   
Title

Competency-Based Training Programs for Aylward Tablet Press

Description

The purpose of this project was to develop structured, competency-based training programs for the operation, changeover, and cleaning of the Aylward Tablet Press.

   
Title

Sterile Operation

Description

The purpose of this project was to design and develop a structured, competency-based, self-instructional training program on Visual Inspection Methods and Techniques.

   
Title

Business Acumen/Field Engagement

Description

This project included creating on-the-job training, evaluation and certification tool design to qualify participants on their ability to execute key Business Acumen competency in the workplace.

   
Title Chem Stock Operator
Description This project conducted a task analysis and developed a self-instructional training program for personnel responsible for weighing and making up product batches. The program included a step-by-step guide to the process illustrated by digital photographs.
   
Title

Maintenance Department Training Needs Analysis

Description

This project analyzed the needs of new hire maintenance training service provided by the Maintenance Department including a final report and recommendations with a suggested plan of action.

   
Title

Business Leadership Training

Description This project developed instructor-led training for supervisors in their Manufacturing Division.  Topics included: collaboration in the workplace, interpersonal skills, manufacturing metrics, and problem solving.
   
Title

Nuclear Pharmacy Training

Description

This project designed a Compliance Training System to educate new and incumbent personnel. This program covered occupational exposure to radiation, general safety, and function-specific exposure.

   
Title

Training Program Design

Description

This one-day custom workshop was designed to prepare designated SMEs to develop competency-based training programs for this finished pharmaceutical facility that is preparing for a pre-approval inspection.

   
Title

Sales Training - Biokinetics

Description

This project involved developing self-instructional materials to be used by the sales force to build knowledge in the area of biokinetics as it relates to nuclear pharmacy.

   
Title Executive Training
Description This project was an 8-hour instructor-led, interactive training program for senior level management covering all components of compliance training.
   
Title

Performance Checklists

Description

This project included detailed checklists that were created for each job in this large manufacturing facility to serve as guidelines for the on-the-job training and for job performance evaluations.

 

 

Title

Leadership Conference

Description

This training delivered our problem-solving workshop to company’s leadership at their 2000 Annual Leadership Conference.

   
Title

Hi-Coater Operator Training

Description

This program was developed to teach and certify coating operators in the non-aqueous tablet coating operation.

   
Title

Pharmacy Operator Rewrite

Description

This project updated the Pharmacy Operator Program based on outlines of existing modules provided by company.

   
Title

Tableting Operator Training

Description

These instructor-led programs were developed to teach and certify compression operators in all aspects of the tableting operations, including Elite 800, Elite 450, and Manesty Mark IV.

   
Title Vet
Description This project involved developing technical skill training programs for Norden 700 and 1400 Operators, Setup Mechanics, and Mechanical Technicians.
   
Title

Pharmacy Operator Chemical Weighing

Description

This classroom and on-the-job training program prepared operators to perform the task involved in chemical weighing.

   
Title

Pharmacy Auditor

Description

This classroom and on-the-job training program prepared operators for QA/QC functions in the pharmacy.

   
Title

Pharmacy Product Development Operations

Description

This classroom and on-the-job training program covered all equipment involved in developing small scale batches of finished pharmaceuticals including Manesty, Aqueous, Coater, Hi-Coater and Elite 450.

   
Title

Company Operator

Description

This classroom and on-the-job training program was designed to train company operator.

   
Title

Training System Project

Description

This program assessed the knowledge and skills required for 100 different job functions and developed standard training plans and proficiency tests to evaluate employees in each job function.

   
Title SOP Coordinator
Description This project provided direct support to manage the entire SOP system.  Responsibilities included re-categorizing the entire SOP inventory, issuing new and revised SOPs, and ensuring the entire SOP network was kept current, including SOP training.
   
Title

SOP Training System

Description

This project included:  creating templates for designing and implementing classroom, self-guided, and on-the-job SOP training programs.

   
Title

Document Management

Description

This project provided supervisor and documentation specialists to process documents that support preclinical and pharmaceutical development activities.  Documents processed included:  SOPs, specifications, and reports supporting preclinical studies.

   
Title

Specification Assistant

Description

This project provided review and coordination of process specifications to support pharmaceutical development activities.  Responsibilities included interfacing with both authors and document management personnel to ensure timely issuance of specifications.

   
Title

Document Processor

Description

This project involved providing full-time contractor services on site to process regulatory- related documentation.

   
Title

Quality System Program

Description

This project involved general consulting services to assist company in implementing their worldwide Quality Systems Program.

   
Title Research
Description This project supported initiatives related to training needs analysis, compliance training process, training program design, and assessment.  This project included developing a training database in Access.
   
Title

Materials in Support of Talent Management & Succession Planning

Description

This training designed and developed the competency-based materials to support the Talent Management and Succession Planning Process.

   
Title

Raising The Bar
This project designed instructor-led virtual classroom guides.

Description

Training Materials for Regional Directors

   
Title

This project developed onboarding training for new Regional Directors.  This provided a user-friendly approach to training, designed to aid Regional Directors in reaching peak performances sooner.

Description

Visual Sops
This project revised Visual SOPs for Packaging Line setup, operation and shutdown, revised SOPs for Quality Assurance, and developed several new SOPs.

   
Title

Responsible Business Communication

Description

This program for training medical affairs staff on responsible business communications ensured that all business communications from SMA adhered to regulatory, legal, and corporate guidelines. 

   
Title Penicillin Manufacturing
Description This classroom and on-the-job training prepared operator to work on all aspects of penicillin manufacturing.
   
Title

Focus on GXPs

Description

This project produced a series of videotapes to help pharmaceutical manufacturing employees focus on their jobs each and every time they do them.

   
Title

Export Compliance Videos

Description

This project developed two television modules to explain export compliance to employees.

   
Title

Centrifuge

Description

This project trained manufacturing personnel in the operation and maintenance of a centrifuge.

   
Title

Videos on Confidential Information

Description

This project developed a series of four videos aimed at explaining confidential and intellectual property information

   
Title Plasma
Description This project developed a consistent manner for plasma donor center sites to screen donors and prepare them to donate blood plasma.
   
Title

Training Program Design

Description

This project provided structured, competency-based technical skilled training programs to production personnel through the development of a detailed self-instructional manual.  This manual will be used to train personnel in the knowledge and skills required to perform the identified process or operate the identified equipment.

   
Title

Training Checklists

Description

This project included task analysis and the development of detailed competency listings to be used for training and qualifying production workers.

   
Title

GMP Training

Description

This project involved presenting basic GMP training to all production employees.

   
Title

Visual SOP Development

Description

This project enhanced existing SOPs in order to increase their effectiveness in promoting consistent compliance with an approved work process.

   
Title

Production Controls

Description

This project studied 30 critical jobs and 35 critical SOPs to develop individual assessments which defined critical knowledge and skills required for Production Control.

   
Title Skilled Operator Training Curriculum
Description This project developed a structured, competency-based curriculum for manufacturing personnel at the company's manufacturing facility
   
Title

eLearning GMP Refresher Training

Description

This training provided an eLearning GMP Refresher program that emphasized personal responsibility in following the GMP regulations.  The program provided three illustrations of those regulations and what can happen when they aren’t followed. The target audience included employees worldwide that specialized in Manufacturing, Quality, Engineering, and Supply Chain.

   
Title

QA Training

Description

This project developed training programs to support the Quality Assurance (QA) curriculum at the company's manufacturing facility in Petersburg, VA. This involved converting 15 instructor-led, annually required QA training programs to eLearning and developing approximately 16 structured, competency-based training programs. These programs will be developed as instructor-led presentations and then converted to eLearning.    

   
Title

cGMP Training

Description

This project developed and implemented training for personnel with little or no GCP background.  The topic was a comparison of the similarities and differences of Commercial vs. Phase III Clinical Manufacturing.

   
Title Good Distribution Practices Training
Description This training developed an eLearning program for Good Distribution Practices.  The training is web-based using Articulate development platform and uses interactive screens moving users to proficiency in self-directed learning.  Testing provides targeted feedback and measures proficiency.  These modules qualify participants on key competencies required for compliance with Good Distribution Practices.
   
Title

Corporate Safety

Description

This project developed a series of eLearning safety programs.

   
Title cGMP Compliance Training Programs
Description This project developed and presented a series of current Good Manufacturing Practices Training Programs.  These programs included GMPs for Manufacturing Stf, GMPs for Maintenance St and GMPs for others.  
   
Title Technical Skill Training Programs-Trident
Description This project developed training programs and materials required to support a skilled-based curriculum for both hourly and salaried personnel.
   
Title Technical Skill Training Programs
Description This project developed structured, competency-based technical skilled training programs for  production personnel. The detailed self-instructional training program provided personnel with the knowledge and skills required to operate the blister pack equipment.
   
Title Technical Skill Training Programs
Description This project provided structured, competency-based technical skilled training programs for
production personnel.
   
Title Technical Skill Training Programs
Description This project developed technical skill training programs for manufacturing personnel at the company’s manufacturing facility.
   
Title CAPA Training
Description This training developed and implemented a technical writing skills program aimed at improving the ability of the staff to document Investigations and CAPA Plans.
   
Title Aseptic Cleaning visual Workplace Instructional
Description This project developed two Visual Work Instruction training modules on Aseptic Cleaning at the company’s facility which provided a structured, competency-based program for training personnel on how to clean facility work areas and small parts.
   
Title Develop. & Administer GMPs
Description This 2-day workshop was designed and facilitated for this training and research institute that guides participants through the creation and implementation of a GMP training program.
   
Title CBT Workshop
Description This project was a competency-based training program design workshop.
   
Title Training Manager Workshop
Description This 3 1/2-day workshop was designed for covering the roles and responsibilities of a Training Manager at a GMP regulated facility.
   

 

 

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