One of the fundamental concepts of “Good Manufacturing Practices” (GMP) is that companies manufacturing and/or testing medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything This GMP Huddle Seminar covers the foundation of the regulations that control the manufacturing and distribution of pharmaceuticals & biologics sold in 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 facilitate efficient and cost effective production and problem resolution. This GMP Huddle Seminar provides a complete overview of the industry requirements as specified by the FDA. It will provide participants with an understanding of common terminology and the role GMP plays 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.
WHO SHOULD ATTEND?
This GMP Huddle is designed for those who work in a cGMP environment, both beginners and advanced professionals. It is designed for all those who have roles and responsibilities that require them to understand and apply cGMP quality principles in 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. "Limited Seats for this INTERACTIVE Huddle Seminar" This Huddle will be extremely useful for quality assurance & quality control managers for effective GMP compliance and proper Vendor Management including periodic vendor audits using various tools and techniques discussed over the 2 day seminar. As this Huddle addresses cGMP regulations, attendees working with finished pharmaceuticals, combination products, biological and APIs will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.
WHO SHOULD ATTEND?
DAY 1 – 19th August (Monday): 09:00 am – 05:00 pm
1. Fundamentals of Good Manufacturing Practice: What is GMP?
a. Purpose of GMP
b. Intro to FDA, FD & C
c. Intro to other regulatory agency, Europe & Canada
d. Importance to our manufacturing – department roles overview
2. Facilities & Equipment
a. Types of Facilities – Solid Dose, Aseptic, Biologics, API – facilities: the role they play
b. Flows – Material, Air, Personnel
c. Lighting, Plumbing & Containment/Contamination
3. Vendors and Materials Control
a. Classification of materials according to Function
b. Material Specifications
c. Vendor Auditing – Qualifying: What are the key things to look for?
d. Vendor Control – Regular Audit of suppliers and contractors; things to look for
e. Control of incoming Materials
f. Container Closure and other GMP functions
g. What the regulations require for reduced testing
4. Process Control: “Master Batch Records and Validation”
a. The validation Master Plan
b. Review and Approval of Master Records
c. Converting the Master Record to a Batch or History Record – Predicate rules and Part 11; What are they really
d. Another New paradigm – Process Analytical technology (PAT)
5. Packaging and Labeling
a. Why is packaging and labeling so important?
b. Controlling labels and other printed materials
c. Examining and storing packaging & labeling
d. Materials; Controlling labeling operations
Q & A, Discussions.
DAY 2 – 20th August (Tuesday): 08:00 am – 05:00 pm
1. Validation (applying cGMPs)
a. Qualification v. Validation; Protocol Development
b. Types of validation
d. Final Reports
2. Regulatory Inspections
a. Purpose of an inspection
b. Reasons for inspections
c. Inspections at your contract sites CMOs and Suppliers – what does it mean to you?
d. GMP Inspections v. Pre-approval inspections
e. EMA inspections – contrast with FDA
f. Health Canada Inspections – contrast with FDA
3. Logistics to manage inspections at your location
a. Information sources about inspections on agency websites
b. Preparation for inspections
c. Overall process – ready room support
d. Receiving and hosting the inspectors
e. Providing documents, Answering Questions
f. Interpersonal Dos and Don’ts for interacting with inspectors
g. Managing Exit discussions at the conclusion
4. Post-inspection communications with the inspecting agency
a. How to write an effective response
b. Common mistakes to avoid
c. Following up to ensure the response is satisfactory
d. When to request a meeting and if granted, how best to handle it
5. Inspections at your Contract Organizations or Suppliers
a. Making sure your CMPs and Suppliers are “PAI ready”
b. Training employees to assure inspection readiness – pitfalls to avoid
c. Conducting mock inspections effectively
A Quiz test is done for participants before the seminar – Answers discussed at the end.
Q & A, Discussions.
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career"(RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).