CBT Program Design Workshop

Foundation Training II

New Supervisor Training

Training Program Design

Research and Development Training Plan

TPD Services

Packaging Line Job Aids

Needs Assessment

Technical Training Services

GMP Training for Executives

Train-the-Trainer

Manufacturing Training Plan

GMP for Operators, Technicians, and Mechanics

Needs Analysis

PeopleSoft Order Management

GMP Meeting Series for Medical Devices

Policy Manual

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.

Training Manual 2007 Update

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

QC Manual - 2007 Update

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

Training & Orientation Manuals Integration Into LMS

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

Policy & Procedures. Manual-2007 Update

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

Policy & Procedures Manual Revisions and Update

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

Global Quality Curriculum

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

Supervisor Handbook

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

Packaging

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

QA Training Curriculum

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

Cell Banking Training

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.

Learning Management System (gLEARN)

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

Quality Overview

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.

Technical Writing

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.

GMP (Good Manufacturing Practices) Meeting Series

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.

Visual Workplace

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

QA/QC Curriculum Development

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

Product Knowledge Videotape

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.

Needs Analysis and Training Plan

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

cGMP Compliance and QC Lab Training Program

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

Set-Up Mechanic Training Program

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

Thiele Traying Machine Change-Over Manual

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

Laboratory Analyst Equipment Training

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

Straight-Through Packaging Mechanical Technician Training Program

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

Adtech Bottle Feeding, AirWash and Filling Machine Training Program

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.

Blow Mold Machine Task Analysis

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

Order Writing

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.

Packaging Line Task Analysis

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

Machine Training Program

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

Web-based Quality Assurance Application

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.

Overview of Drug Product Development
.

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

Bolus Manufacturing Training Program

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.

H and K Encapsulator Training Program

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.

Business Acumen

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

Quality Auditor Web Site

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. 

Validation Training

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.

Competency-Based Training Programs for Aylward Tablet Press

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

Sterile Operation

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

Business Acumen/Field Engagement

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.

Maintenance Department Training Needs Analysis

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.

Business Leadership Training

Nuclear Pharmacy Training

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.

Training Program Design

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.

Sales Training - Biokinetics

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.

Performance Checklists

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.

Leadership Conference

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

Hi-Coater Operator Training

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

Pharmacy Operator Rewrite

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

Tableting Operator Training

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.

Pharmacy Operator Chemical Weighing

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

Pharmacy Auditor

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

Pharmacy Product Development Operations

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.

Company Operator

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

Training System Project

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.

SOP Training System

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

Document Management

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.

Specification Assistant

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.

Document Processor

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

Quality System Program

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

Materials in Support of Talent Management & Succession Planning

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

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

Training Materials for Regional Directors

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.

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

Responsible Business Communication

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. 

Focus on GXPs

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

Export Compliance Videos

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

Centrifuge

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

Videos on Confidential Information

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

Training Program Design

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.

Training Checklists

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

GMP Training

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

Visual SOP Development

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

Production Controls

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

eLearning GMP Refresher Training

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.

QA Training

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.    

cGMP Training

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.

Corporate Safety

This project developed a series of eLearning safety programs.