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In-House Training Workshops
(always customized!)
These are the different In-House Training Workshops we offer. More information can be found below:

Project Management
Customer Relations Management
Business Proposal Writing
Creating Personalized Employee Development Plans
Persuasive Presentation Skills
Complying with ISO 13485
Introduction to Risk Analysis
21 CFR Part 11 Overview
GMP in the Labs
Introduction to Investigations and Root Cause Analysis
The Basics of Auditing
GMP Overview for Pharmaceuticals
GMP Mini-Workshops
QSR Overview - The Medical Device Quality System Regulations
ISO 9000:2000 in a GMP Environment
GMP Refresher
Train-the-Skills-Trainer
Improved Training Using SOPs
Effective SOP Writing and Training

Note: All workshops are designed for a maximum of 25 participants. Call or e-mail for quotation.

Project Management

This one-day, highly participative workshop covers all major aspects of project management using customized facility project examples. Attendees will apply the project management model to an actual project in a series of building block small group exercises. The course also stresses the importance of cross-functional project teams.

Customer Relations Management

Everyone has customers, whether they are internal or external. This exciting half-day workshop allows attendees to identify their "customers", review a four-part blueprint for customer service, and practice new skills sets with real life facility examples aimed at improving overall customer service and satisfaction.

Business Proposal Writing

This half-day, real-world workshop focuses on how to logically prepare a concise, persuasive business proposal such as approval of capital expenditure or staff addition. Attendees will learn how to perform a situation analysis, logically evaluate alternatives, and select the best option. They will discuss ways to create concise and effective recommendations and rationales, and will review the components of an implementation action plan. There will be a hands-on business proposal development and writing component.

Creating Personalized Employee
Development Plans

This interactive half-day workshop is the perfect complement to the annual performance review process. Attendees review the total career development cycle, and then complete an individual Strength Deployment Inventory. The results are then used to develop a personalized employee development action plan.

Persuasive Presentation Skills

This one-day highly intensive and interactive workshop is designed to assess and strengthen persuasive presentation skills. Attendees will do a self-assessment of personal communications strengths and development areas. New presentation skill sets will be introduced and practiced, with the ultimate goal of enhancing overall professional communication image and credibility.

Complying with ISO 13485

ISO 13485 is ISO for medical devices. What are the recent changes and what do they mean for your compliance program? This half-day session covers the requirements of this standard, and how it differs from ISO 9000:2000. Attendees will perform a gap analysis of their compliance status, and formulate action plans for following the new requirements.

Introduction to Risk Analysis

This half-day workshop provides solid foundation knowledge on the FDA's increasing interest in risk analysis and risk management, and covers the basic "how to's" in conducting risk analysis at your facility. Applications to both Part II and GMP/QSR are covered, and attendees get hands-on practice using facility data.

21 CFR Part 11 Overview
(Electronic Records, Electronic Signatures)

This half-day workshop is an excellent introduction to the FDA's newest regulation. Specific requirements and definitions of Part 11 are detailed, and attendees will determine what records actually fall under the Part 11 rule. The session is also a good train-the-trainer for managers/supervisors who need to spread the word on Part 11.

GMP in the Labs

This half-day workshop covers GMP requirements with a special emphasis on the application to QC/QA laboratory settings. This highly interactive seminar focuses on the labs’ role in ensuring high quality products and addresses specific issues that lab employees face on a daily basis.

Introduction to Investigations and
Root Cause Analysis

This half-day interactive workshop emphasizes practical skills for improving the investigation process. Basic root cause analysis tools are explored through description and facility-customized exercises to provide attendees hands-on practice they can take back to the job.

The Basics of Auditing

This 1-day real-world course looks at auditing from the perspective of both the auditor and the auditee; the objective is to focus on skills and strategies to maximize the audit experience. The sessions covers audit preparation, conducting the audit, and audit follow-up and corrective action. Interesting exercises give attendees a chance to practice skills.

GMP Overview for Pharmaceuticals

This 1-day workshop is a good introduction to or review of the requirements of the drug GMPs. The morning section covers a brief history of industry regulation, a detailed review of the GMP Regulations and FDA inspections. The afternoon section focuses on documentation and housekeeping issues. The workshop is customized with facility-specific examples and contains interesting hands-on small group exercises.

GMP Mini-Workshops

These 1-hour workshops are totally hands-on and perfect for production operators through supervisors. Choose from 3 topics: production cycle, quality testing or documentation. Attendees work with facility data for a customized, real-life training experience.

QSR Overview - The Medical Device Quality
System Regulations

This 1-day workshop provides a comprehensive review of the revised medical device quality system regulation. Additional topics include a brief history of industry regulation, FDA QSIT inspections and detailed focus on documentation and housekeeping issues. Theory meets practice when attendees get to rate their compliance status and participate in other facility-customized exercises.

ISO 9000:2000 in a GMP Environment

What is ISO 9000:2000? How does it affect compliance with GMP? This ˝-day program covers the basic requirements of the updated ISO 9000 series of standards and compares them to the GMP Regulations in both philosophy and specifics. The topics of management responsibility, documentation, auditing, training and registration will be covered in detail. Individuals complete an ISO 9000 compliance exercise and develop a custom action plan to ensure compliance.

GMP Refresher

This 1-day workshop meets the requirement of on-going GMP training using a highly interactive, interesting format with emphasis on customized real-world small group training exercises that vividly connect GMP theory with on-the-job reality. Attendees review requirements, take a compliance benchmark reading and participate in up to 3 small group projects: "Tracking Quality", "Testing Quality", and "Documenting Quality".

Train-the-Skills-Trainer

Line supervisors are often an untapped resource for effective skills training. This 1-day workshop is specifically designed to motivate and teach line supervisors how to conduct/reinforce skills training as part of regular job responsibilities. Basic training concepts - from needs analysis through design - are covered with continual application to OJT situations. Supervisors complete step-by-step worksheets to assess current training status and plan upcoming programs. Mini-presentations give practice in oral communications skills.

Improved Training Using SOPs

Employees need to know the information found in SOPs, but how do you train using SOPs besides reading them point-by-point? This 1-day hands-on workshop explores a wide variety of creative and easy methods to review and train on SOP content. Attendees get to practice, demonstrate and rank the approaches using actual facility SOPs and will leave with a personalized list of successful ideas.

Effective SOP Writing and Training

This 1-day hands-on workshop explores guidelines and exercises on clear SOP writing and review, and demonstration and ranking of a wide variety of methods for more interesting and effective content training. Attendees use actual facility SOPs for all exercises.

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