3-Day Annual GMP Master Class for 2022 – Virtual Seminar

  • Product Id : SEM3560
  • Category :
  • Presenter :
  • Scheduled On : February 01 2022 11:00 am
  • Duration : 3 Days

cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products.

It is crucial, for any entity to be compliant, that every individual within the organization fully understand and adhere to these regulations in the course of

Adherence to those regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug and medical device products meet their quality standards.

The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.
Accordingly, the “c” in cGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago are less than adequate by today’s standards.

It is important to note that cGMPs are minimum requirements. Many manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

Why You Should Attend:
Understanding GMP requirements, refreshed on a yearly basis is critical to maintain high-GMP standards in your company. Knowledge and skill surrounding the application and practice of GMPs is fundamental to avoiding regulatory issues. It’s simple – you have to do it and you and your team must comply. You cannot assume that once taught, the content associated with GMPs will be retained from year to year. As human beings, we tend to forget over time and as we forget, we also get careless. In the health sciences there is no margin for error or tolerance for carelessness. This training will provide foundation to your GMP training.

Learning Objectives:

  • List and describe the regulations governing Good Manufacturing Practices
  • State the personal responsibilities as they relate to GMPs.
  • List and describe the regulations in the 21 CFR regulations that pertain to GMPs.
  • Explain how to prepare for a GMP inspection
  • List and describe the consequences of not being prepared for an FDA inspection
  • Explain how the FDA inspection is structured and conducted
  • Explain how the organization should be structured for the FDA Inspection
  • Explain the importance of truthfulness when interacting with FDA inspectors
  • List and describe the tricks inspectors use to elicit information
  • Explain how employees should behave during an inspection
  • Explain how organizations should handling adverse findings at the completion of an inspection

Who Should Attend:
Virtually everyone in the health sciences, everyone within the organization, can benefit and in most cases, is required to attend periodic GMP training.

  • Quality Departments
  • Production Departments
  • Compliance Departments
  • Engineering Departments
  • Manufacturing Departments
  • Operations Departments

SEM3560

Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.

DAY 1 : (11 AM – 3 PM)

GMPs – Government Regulations
– What are the regulations governing Good Manufacturing Practices?
– Your responsibilities
– Pertinent GMP topics as per the code of Federal Regulations
– Quality Management
– Personnel
– Premises and equipment
– Documentation
– Production
– Quality Assurance
– Materials management
– Production and in-process controls
– Packaging and labeling
– Storage and distribution
– Laboratory controls
– Validation
– Change control
– Rejection and re-use of material
– Complaints and recalls
– Supplier controls

DAY 2 : (11 AM – 3 PM)

GMP Inspections
– Preparing for a GMP Inspection
– The consequences of not being ready
– The specific areas that are inspected during a GMP inspection

DAY 3 : (11 AM – 3 PM)

FDA Inspection Tips and Recommendations
– The FDA Inspection – how is it structured and conducted
– Responding and organizing for the FDA Inspection
– Importance of truthfulness
– Importance of knowledgeability and confidence
– FDA Tricks to elicit information
– Arguing and challenging
– Behavior during the inspection
– Importance and role of documentation
– Effective communication skills
– Being deceptive
– Opinion versus fact
– Phrases never to say
– Handling adverse findings during the inspection

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a $300 administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance