Industries: Pharma / Biotech

Good Manufacturing Practices Training | GMP Course

Course Director: Steven A. Ostrove, Ph.D.  
Course Cost:  $2650.00 Regular Registration / $2450.00 Early Bird  (30 Days in Advance)

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast and Lunch Included)

This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.

Each section of 21 CFR 211 (Current Good Manufacturing Practices [CGMP] for Finished Pharmaceuticals) will be covered interspersed with references from 21 CFR 600/610 (Biological Products: General) and 21 CFR 820 (Quality Systems Regulations). Although CGMP refers to 21 CFR 210/211 the other Parts (600 and 820) rely on Part 211 as well. In addition to the above, ICH, EU, and other comparisons will be made in order to provide a complete understanding of the regulations.

The GMP course provides a complete overview of the industry requirements as specified by the FDA.

Who Should Attend

This three-day Good Manufacturing Practices training is designed for those who work in a cGMP environment, from beginners to advanced professionals. It is designed for those whose roles and responsibilities require that they understand and apply cGMP quality principles to their job as related to product discovery, development, and/or manufacturing. It will benefit professionals who are new to industry by presenting an overview of the important concepts in a logical and natural sequence so they can begin to understand GMP regulations and begin applying them effectively. The GMP course is also designed to help both the "cGMP Intermediate" and the "cGMP Professional" by providing continuity from product development through facility construction and final product release. Understanding the ‘why' of cGMP principles along with valuable insights and examples that will assist them in their quality decision-making, as well as, demonstrating ways to make their present systems more effective.

This course is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors, training and production managers, and management interested in effective GMP compliance tools and techniques.

As this course addresses cGMP regulations, attendees working with finished pharmaceuticals, combination products, biological, APIs or devices will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.

First Day

Section 1 - Introduction to the Regulations

  • What are the GMPs
  • Intro to the FDA
  • Intro to the FD & C

Section 2 - Other Regulatory Agencies

  • EU and other regulations
  • Importance to our manufacturing

Section 3 - Organization and Personnel Roles and Responsibilities

  • Department Roles/Functions
  • Interactions
  • Training
  • Change Control

Second Day

Section 4 - Facilities & Equipment

  • Types of Facilities – Solid Dose, Aseptic, Biologic, API
  • Facilities and Equipment – the role they play
  • Flows – Material, Air, Personnel
  • Lighting, Plumbing, & Containment/Contamination

Section 5 – Vendors and Materials Control

  • Classification of materials according to function
  • Material specifications
  • Vendor Auditing - qualifying, and controlling suppliers and contractors
  • Control of incoming materials
  • Container Closure and other GMP functions
  • What the regulations require for reduced testing

Section 6- Process Control: “Master Batch Records and Validation”

  • The Validation Master Plan
  • Review and Approval of Master Records
  • Converting the Master Record to a Batch or History Record
  • Predicate rules and Part 11 – What are they really
  • Another new paradigm-Process Analytical Technology (PAT)

Section 7 - Packaging and Labeling

  • Why is packaging and labeling is so important?
  • Controlling Labels and other Printed Materials
  • Examining and storing Packaging & Labeling Materials
  • Controlling labeling operations

Section 8 - Validation (applying CGMPs)

  • Qualification v. Validation
  • Protocol Development
  • Types of Validation
  • Executions
  • Final Reports

Third Day

Section 9 - Laboratory Controls

  • Sampling
  • Analytical methods-Scientific Basis, Approval, & Validation
  • Pharmacopeias
  • Methods Validation Requirements
  • Equipment Qualification Requirements
  • Controlling Reagents & Reference Standards
  • Laboratory Data-Notebooks, LIMS, & Disks
  • Equipment Controls
  • Using a Contract Laboratory

Section 10 - Product Release and Distribution

  • QA Responsibilities in Product Release
  • Why perform testing on finished products?
  • Batch Record Review
  • Recalls

Section 11 - Records – Reports – Investigations

  • Storing Documents and Retains
  • When Things Go Wrong
  • Getting to the Root Cause

Section 12 – Wrap Up

  • Discussion of Hot Topics
  • Consent Decree Case Studies
  • Questions & Answers

Learning Objectives

All participants will gain a fundamental knowledge of the basis of CGMP regulations, and the necessity of implementing them in daily operations. Additionally, this course is intended to give participants an introduction to the CGMP regulations and their application to laboratory activities, manufacturing processes and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.

The course also provides participants with an understanding of common terminology and the role GMPs play in their day-to-day responsibilities. Focus is given to the regulatory nature of CGMP compliance, managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts. Consequences of non-compliance will be examined to underline the importance of implementing and maintaining a robust CGMP posture.

  • Be able to understand and apply GMP concepts to decision making in a managerial role
  • Understand facility and equipment design implications on the final product
  • Know and understand the difference between commissioning, qualification and validation and how, where and why they are applied
  • Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
  • Know how to better locate regulatory information and interpret, assess, and make decisions concerning GMP issues

Testimonials

"The Course Director had a lot of experience in a lot of different areas. I appreciated that he shared them with us. You could tell he knows what he’s talking about. The instructor’s level of experience is typical of other CfPIE courses I’ve attended." Ashley G., Doc Cntrl/Training Spec, Wright Medical
"The course provided a thorough introduction to 21CFR and regulatory agency principles. I enjoyed the open discussion and numerous real life examples." Aimee S., QA Specialist, Selecta Biosciences
"The course provided great examples and the Director was very engaging." Jordan O., QA Training Specialist, Akorn
"The instructor was knowledgeable and had a good sense of humor." Anthony R., Compliance Auditor, Clorox
"I’d rate this course as above average as the instructor was experienced, led the course at a perfect pace and was well prepared." Betty E., Sr. Dir., FP&A, Reata Pharmaceuticals
"Very interactive, I have taken courses in the past in which I was talked to, not talked with. The instructor talked with me." Homayoun S., Quality Assurance, Portola Pharmaceuticals
"The Course Director is very knowledgeable and very clear in his presentation. It was easy talking with him and he welcomed all questions. His vast and varied experience along with his stories and examples were very helpful." Stephanie M. , QA Specialist, Mersana Therapeutics
"I only take courses with CfPIE as the instructors are so highly qualified." Megha S., Document Control QA, Granules Pharmaceutical
"The Course Director's energy and knowledge is unparalleled." Brett R., Chemist, Alchemix
"Great pace and sufficient detail and the instructor injected great examples to elaborate on the points discussed." Doug T., Project Manager, OncoMed
"Excellent! This course was well structured and the presentation was effective. The instructor's style of presenting made the details easy to fully comprehend." Pete D., Business Development Manager, Wacker Biosolutions
"Training was extensive and covered many topics within the industry. This was useful in that some parts, if not most, apply to everyone. The instructor has had many years in the industry. This was useful as it allowed him to have the knowledge to teach the class and share real-life examples that he had encountered over the years." Nadia B., QC Coordinator, Biotest Pharmaceuticals
"Instructor was very knowledgeable and had numerous examples from the industry to share with the class." Tyler L., Specialist I – QA, Emergent BioSolutions
"Very informative! Gave great examples from experience that put topics into perspective. The course materials provided were great! I am sure I will be using these for reference when I head back to work. I particularly like the definitions/terms and abbreviations." Johana R., Regional Manager QA, Biotest Pharmaceutical
"Really enjoyed the three days of training, one of the best I've attended and really learned a lot that will be helpful in the next audit." Jayne K., Research Analyst, Janssen Diagnostics
"This course presented ideas or techniques that are useful to me. The Course Director was very knowledgeable and presented his material very well. Great training" Carlos, Mfg. Tech II, Biotest Pharmaceuticals
"Thank you for the amazing cGMP course! I didn't know what to expect going into the course but it far exceeded anything I would have imagined. It was very valuable and I learned so much from it! I hope to take another one of your courses in the future!" Elizabeth F., Associate Scientist, Janssen Diagnostics, LLC
"Great course, well-presented, and informative." Milissa R., QA Engineer, Biotest Pharmaceuticals
"The Course Director was a great instructor. His ability to get everyone into discussions over the topics was outstanding. I left there with many different ideas of how other companies approach the daily struggles we all face while complying with cGMP." Susan, Director of Operations/Quality Assurance, RemedyRepack
"The Course Director was very knowledgeable on the subject of GMP. I very much appreciated his real world experiences." Douglas S., Manager, External Manufacturing Operations, McNeil Consumer Health
"Really nice course! I learned a lot. Thank you" Karla V., Project Manager; ABM Industries
"This course was a perfect introduction for me into the GMP regulations. I found the Course Director did a wonderful job in keeping us interested in the subject" Mercedes S., Senior Scientist; Bluebird Bio
"The Course Director did an excellent job applying real scenarios to the GMPs. The 'warning letter' conversations were extremely informative and illustrated the importance of compliance. I also appreciated the discussions concerning master and control records and guidance around use, verification, and control. I enjoyed the discussion on the relationship between GMP, ICH and Eudralex. Of note, the Course Director did a great job engaging the class and creating a very interactive environment; the course went by very quickly." Christopher P., Director of Manufacturing, Aastrom Biosciences
"The Course Director was so engaging in his style. And his first-hand experience and accumulated knowledge were immensely beneficial. I have never attended a GMP class that was so chock full of real experiences and examples. Also, the class size was perfect!" Margaret C., Principal Scientist, Int'l Compliance, Mary Kay Inc.
"I found the course very informative and interesting, taught by a knowledgeable and engaging course director, explaining cGMP theory as well as appropriate examples." Vilma C., Technologist, Pliva Croatia doo
"The course was very informative. The Course Director is extremely versed in the material presented, and he made it very easy for those in attendance to follow. I would be interested in receiving more training from this Course Director. I would recommend this class to everyone in this business." Elder B., Mfg. Tech., Biotest Pharmaceuticals
"The Course Director's Background was very relevant and provided a very sound approach on GLPs & GMPs. I appreciated the real-life application and knowledge." Mark W., Senior Analytical Chemist, Rockline Industrie
"This was the first time an instructor has covered all topics…BRAVO! The Course Director was excellent in communicating his ideas because of vast experience and knowledge and they had excellent presentation skills. I especially liked the case studies and interaction." Jennifer P., Training Site Lead, MedImmune
"Even though I am in clinical, many of the GLP/GMP specifics gave me a broader picture of where areas of GXP may intertwine. It was great to see the "big picture" in the area of pharmaceutical regulations." Kelly F., Compliance, Pfizer
"I found the course to be extremely informative and useful as I have never worked in a GMP environment until now, and therefore this course served its purpose." Lakshmi R., Senior Research Associate/Quality Specialist, Neose Technologies
"This course is very good for individuals beginning their understanding of GMP regulations." John S., COO, Semafore Pharmaceuticals

Video

Good Manufacturing Practices (cGMP) Course

In this video, both an attendee and instructor Steven A. Ostrove, Ph.D., a Bio-Pharmaceutical industry veteran, discuss the benefits of our approach to training courses.


RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.